October 15, 2003
03-42
_______________________________
PRODUCT
Fresh picked crab meat (retorted in shell initially) which is stored
under refrigeration and is packed into 16 oz. semi-opaque white
plastic containers with white plastic snap on lid, in four different
styles (grades): Claw Crabmeat, Lump Crabmeat, Jumbo Lump Crabmeat
and Premium Cocktail Claw Crabmeat. Each container has the additional
labeling as follows: "STEAMED UNDER PRESSURE ROCK LANDING SEAFOOD
Fresh Picked CRAB MEAT NET WT. 16 OZ. FL-31822-C KEEP REFRIGERATED." Recall
# F-544-3.
CODE
All product produced on May 13, 2003 through June 27, 2003 and also
product produced and shipped on July 14, 2003 which has the following
codes printed on the plastic container lids: 05/13/2003, 5/16/03,
01051803, 04052203, 02052703, 05053003, 05060603, 03061103, 04061203,
02061703, 02062403, 05062703 and 01071403.
RECALLING FIRM/MANUFACTURER
Rock Landing Seafood, Panacea, FL, by telephone on July 8, 2003,
by letter on July 11, and July 14, 2003. FDA initiated recall is
complete.
REASON
The firm violated its Consent Decree of Permanent Injunction by
continuing to distribute ready-to-eat crab meat products to consumers
without abiding by any of the preliminary conditions specified in
the signed Consent Decree.
VOLUME OF PRODUCT IN COMMERCE
2600-16 oz. containers.
DISTRIBUTION
NY, MD and GA.
_______________________________
PRODUCT
Geisha Chunk Light Tuna In Water, Vegetable Broth and Salt Added,
NET WT.6 OZ. (170g), Product of Philippines. Recall # F545-3.
CODE
SJBC OOCA 2614; SJBC OOCA 2618; SJBC OOCA 2619; SJBC OOCA 2617;
SJBC OOCA 2615.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kawasho International USA Inc, New York, NY, by
letter on December 17, 2002.
Manufacturer: Ocean Canning Corporation, Philippines. FDA initiated
recall is complete.
REASON
Tuna in pouches may be post-processing contaminated with food pathogens.
VOLUME OF PRODUCT IN COMMERCE
1,162 cases of 50 each.
DISTRIBUTION
MO, OH, AR, MI, and ID.
_______________________________
PRODUCT
a) Chocolate Chip Gelato 5 liter. Recall # F-546-3;
b) Chocolate Gelato 5 liter. Recall # F-547-3;
c) Vanilla Gelato 5 liter. Recall # F-548-3;
d) Pistachio Gelato 5 liter. Recall # F-549-3;
e) Peach Sorbet. Recall # F-552-3.
CODE
All product on the market at the time recall was initiated.
RECALLING FIRM/MANUFACTURER
Marino Lookout Farm, Natick, MA, by telephone on June 13, 2003.
State of Maine initiated recall is complete.
REASON
Products fail to bear an identity and ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
104 units.
DISTRIBUTION
MA and ME
_______________________________
PRODUCT
Crowded Cranberry Muffin Batter, Frozen, sold in 10-lb plastic pails,
2 per case. Labeled in part, “Main Street Gourmet #1150 Crowded
Cranberry. Recall # F-553-3.
CODE
Lot # 0528014.
RECALLING FIRM/MANUFACTURER
Feature Foods, Inc., Cuyahoga Falls, OH, by fax on July 3, 2003
and September ll, 2003. Firm initiated recall is ongoing.
REASON
Product contains wood fragments.
VOLUME OF PRODUCT IN COMMERCE
17 cases.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Deluxe Assortment Gift Box, containing various pieces of chocolate
coated candy. The candy mix includes several pieces of orange and
raspberry flavored jelly candy, packaged in 8 oz. and 16 oz. cardboard
boxes. Recall #F-555-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Walnut Creek Chocolate Co., Inc, Walnut Creek, OH, by telephone
and letter on September 22, 2003 and September 24, 2003. FDA initiated
recall is ongoing.
REASON
The product contains undeclared FD&C colors Yellow #5 and Yellow
#6, Red #40, and Blue #1.
VOLUME OF PRODUCT IN COMMERCE
274 boxes.
DISTRIBUTION
OH and PA.
_______________________________
PRODUCT
Product is packed into a metal can with a paper label which reads
in part "***Robinson Crusoe Smoked Atlantic Boneless and Skinless***NET
WT 6/58 OZ (190g) DRAINED WT 5 1/4 OZ (150g)***PRODUCT OF CHILE***"UPC
Code: 0-8477360253-1 Item number used at the Ventura Warehouse:
3202503. Recall # F-556-3.
CODE
Product code on bottom of cans are: 051101, 081101, 051201, 160202,
080801, 220602, 041002, and 181002.
RECALLING FIRM/MANUFACTURER
Rodriguez, Ventura, Inc., San Juan, PR, by telephone on June 6,
2003. Firm initiated recall is ongoing.
REASON
The product did not receive an adequate thermal process to eliminate
pathogens of public health concern, including Clostridium botulinum
spores.
VOLUME OF PRODUCT IN COMMERCE
125 cases/12 cans (1500 cans).
DISTRIBUTION
PR.
_______________________________
PRODUCT
a) Strawberry Sorbet, 5 liter. Recall # F-550-3;
b) Raspberry Sorbet, 5 liter. Recall # F-551-3.
CODE
All product on the market at the time recall was initiated.
RECALLING FIRM/MANUFACTURER
Marino Lookout Farm, Natick, MA, by telephone on June 13, 2003.
State of Maine initiated recall is complete.
REASON
Products fail to bear an identity and ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
MA and ME
_______________________________
PRODUCT
Kraft Handi-Snacks Pudding, Chocolate Fudge flavor; four pudding
cups per sleeve, Net Wt. 14 oz., 12 sleeves per case; Kraft Foods
North America, Inc., Rye Brook, NY. UPC #24000-02893. Recall # F-558-3.
CODE
Lot ‘3067RCxxxx/FUDGE’, where the xxxx is a 4-digit
time code. This code is printed in ink on the side of each cup.
The affected product has the filler cup positions of ‘15’, ‘16’, ‘28’ or ‘32’ embossed
into the plastic on the bottom of each cup, above the recycling
triangle with a 7 inside the triangle and ‘other’ below
the triangle.
RECALLING FIRM/MANUFACTURER
Kraft Inc., Northfield, IL, by e-mail or fax on May 3, 2003. Firm
initiated recall is complete.
REASON
Pudding is liquefied due to contamination with Bacillus subtillis.
VOLUME OF PRODUCT IN COMMERCE
324 cases.
DISTRIBUTION
TX, OK, CO, AR and LA.
_______________________________
PRODUCT
Fruit Cocktail in light syrup. Rykoff-Sexton, International. Net
Weight 106 oz (6 lbs. 10 oz) 3.01 kg. Ingredients: Diced Peaches,
Diced Pears, Water, Sugar, Grapes, Pineapple Segments, Halved Cherries,
Citric Acid and Artificial Red Coloring. Product of Greece. Recall
# F-559-3.
CODE
PPFC6L01345.
RECALLING FIRM/MANUFACTURER
Rema Foods Inc, Englewood Cliffs, NJ, by fax on April 14, and April
15, 2003. FDA initiated recall is complete.
REASON
Fruit Cocktail is unfit for food due to contamination with yeast.
VOLUME OF PRODUCT IN COMMERCE
1633 cases.
DISTRIBUTION
CT, FL, IL, MA, MD, NJ, PA, and SC.
_______________________________
PRODUCT
Hi-C Strawberry Kiwi Kraze juice drink, 128oz. muti-serve plastic
bottles. Recall # F-560-3.
CODE
APR1204 PW1, XX:XX CT349 (XX:XX military time).
RECALLING FIRM/MANUFACTURER
Coca Cola, Atlanta, GA, by letter on August 20, 2003. Firm initiated
recall is complete.
REASON
Product may contain a different flavor, Hi-C Fruit Pow. The Fruit Pow contains
ingredients, including pineapple juice, that are not listed on the label of
the Strawberry Kiwi Kraze.
VOLUME OF PRODUCT IN COMMERCE
1480 cases, 4/128 oz. bottles per case.
DISTRIBUTION
IA, IL, KS, MN, MO, and NE.
_______________________________
PRODUCT
Haloperidol Injection, USP, 5 mg/mL, 1 mL vial, Rx Only, For Intramuscular
Use, Sterile; American Pharmaceutical Partners, Inc., Schaumburg,
IL: NDC 63323-474-01. The product was also sold under the AmeriNet
Choice label: Haloperidol Injection, USP, 5mg/mL, 1 mL vial, Rx
Only, For Intramuscular use, Sterile. Recall # D-328-3.
CODE
Lot Numbers: APP label: 111010, 111139, 111178, 111217, 120231,
120264, 120359, 120447,120691, 120725, 120838, 120917, 121028, 121049,
121468, 130281;
AmeriNet Choice label: 111217, 120628, 121468 and 130281.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters
on August 13, 2003 and August 26, 2003. FDA initiated recall is
ongoing.
REASON
Manufacturing Validation: The bulk solution mix time was not completed
as per the validated process time.
VOLUME OF PRODUCT IN COMMERCE
2,256,625 vials.
DISTRIBUTION
Nationwide and Puerto Rico.
_______________________________
PRODUCT
Evista Tablets (Raloxifene HCl), 60 mg, 7 tablets blister pack,
Rx Only. Recall # D-331-3.
CODE
7AA26P (1-FEB-2005), 6AE83P (1-OCT-2004), 6AE76P (1-AUG-2004), 6AD24N
(1-JUN-2004), 6AD20N (1-JUN-2004), 6AA91P (1-MAR-2004), 6AA90N (1-MAR-2004),
5AK53N (1-FEB-2004), 5AJ62N (1-DEC-2003), 5AJ51N (1-NOV-2003), 5AH97N
(1-OCT-2003), 5AG47N (1-SEP-2003), 5AG39N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter on August 8, 2003.
Firm initiated recall is ongoing.
REASON
Mislabeling; Lot number and expiration date are not printed on the
external carton labeling.
VOLUME OF PRODUCT IN COMMERCE
13 sample pack lots.
DISTRIBUTION
Nationwide, Cyprus, Lebanon, and Malta.
_______________________________
PRODUCT
Amaryl tablets (Glimepiride), 4 mg, 100 tablet blister pack, Rx
Only. Recall # D-332-3.
CODE
Lot number: 1054540.
RECALLING FIRM/MANUFACTURER
Aventis Pharmaceuticals Inc., Kansas City, MO, by letters on July
31, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure: stability (18 month test station).
VOLUME OF PRODUCT IN COMMERCE
7,032/100-tab boxes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Prozac Capsules Weekly (Fluoxetine Hydrochloride), Delayed Release
Capsules, 90 mg fluoxetine, 4 capsules blister pack, Rx Only. Recall
# D-342-3.
CODE
6RH73N (1-NOV-2004), 6RH36N (1-OCT-2004), 6RC15P (1-AUG-2004), 6MF17R
(1-JUL-2004), 6RA33V (1-AUG-2004), 6MG40N (1-AUG-2004), 5MX93N (1-FEB-2004),
5NC81N (1-OCT-2003), 5MS53N (1-OCT-2003), 5MS52N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter on August 8, 2003.
Firm initiated recall is ongoing.
REASON
Mislabeling; Lot number and expiration date are not printed on the
external carton labeling.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1833-3.
CODE
Unit number R59169.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on April 11, 2003.
Firm initiated recall is complete.
REASON
Blood product, corresponding to a blood product that was associated
with an adverse reaction in a recipient and may have been contaminated
with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Human Tissue of various types. Recall # B-1834-3.
a) CryoVein, Saphenous Vein;
b) CryoGraft, Hemi Patellar Tendon;
c) CryoGraft, Medial Meniscus-Bone-Left;
d) CryoGraft, Medial Meniscus-Bone-Right;
e) CryoGraft, Lateral Meniscus Bone-Right;
f) CryoGraft, Lateral Meniscus-Bone-Left;
g) CryoArtery, Pulmonary Artery;
h) CryoArtery, Pulmonary Hemi-Artery;
i) CryoArtery, Ascending Thoracic Aorta;
j) CryoArtery, Descending Thoracic Aorta;
k) CryoGraft, Achilles Tendon;
l) CryoGraft, Quadriceps Tendon;
m) Semitendinosus/Gracilis Tendons;
n) CryoVein, Femoral Vein with valve;
o) CryoVein, Femoral Vein;
p) CryoGraft, Pericardium;
q) CryoArtery, Alt. Ascending Thoracic Aorta;
r) CryoGraft, Pulmonary Branch Patch;
s) CryoGraft, Pulmonary Trunk Patch;
t) CryoGraft, Patellar Tendon, Whole.
CODE
Donor #20893, Serial #3915069, Model #V010,
Donor #20727, Serial #3917584, Model #V010,
Donor #20727, Serial #3917576, Model #V010,
Donor #20668, Serial #3894578, Model #V010,
Donor #20668, Serial #3894886, Model #V010,
Donor #19912, Serial #3864928, Model #V010,
Donor #19912, Serial #3864901, Model #V010,
Donor #19236, Serial #3890783, Model #V010,
Donor #19236, Serial #3890791, Model #V010,
Donor #19005, Serial #3821323, Model #V010,
Donor #18498, Serial #3829979, Model #V010,
Donor #18019, Serial #3822427, Model #V010,
Donor #18019, Serial #3822451, Model #V010,
Donor #18019, Serial #3822478, Model #V010,
Donor #17747, Serial #3806251, Model #V010,
Donor #17747, Serial #3806278, Model #V010,
Donor #17740, Serial #3804798, Model #V010,
Donor #17740, Serial #3804771, Model #V010,
Donor #17740, Serial #3804801, Model #V010,
Donor #17391, Serial #3793796, Model #V010,
Donor #17391, Serial #3793788, Model #V010,
Donor #17391, Serial #3793761, Model #V010,
Donor #16823, Serial #3771725, Model #V010,
Donor #16823, Serial #3771733, Model #V010,
Donor #14798, Serial #3703891, Model #V010,
Donor #14798, Serial #3703827, Model #V010,
Donor #14493, Serial #3713091, Model #V010,
Donor #14493, Serial #3713083, Model #V010,
Donor #21068, Serial #3921948, Model #V010,
Donor #21068, Serial #3921921, Model #V010,
Donor #20457, Serial #3888436, Model #V010,
Donor #20457, Serial #3888428, Model #V010,
Donor #20309, Serial #3889394, Model #V010,
Donor #20309, Serial #3889408, Model #V010,
Donor #20170, Serial #3893944, Model #V010,
Donor #20170, Serial #3893952, Model #V010,
Donor #20031, Serial #3869318, Model #V010,
Donor #20031, Serial #3869547, Model #V010,
Donor #19564, Serial #3854177, Model #V010,
Donor #19564, Serial #3859169, Model #V010,
Donor #19195, Serial #3863492, Model #V010,
Donor #19195, Serial #3863506, Model #V010,
Donor #19195, Serial #3863484, Model #V010,
Donor #318933, Serial #3845508, Model #V010,
Donor #318933, Serial #3845516, Model #V010,
Donor #18788, Serial #3837378, Model #V010,
Donor #18788, Serial #3817377, Model #V010,
Donor #18187, Serial #3816087, Model #V010,
Donor #18187, Serial #3816052, Model #V010,
Donor #18187, Serial #3816044, Model #V010
Donor #18187, Serial #3816079, Model #V010,
Donor #18170, Serial #3817067, Model #V010,
Donor #18170, Serial #3817075, Model #V010,
Donor #17798, Serial #3810429, Model #V010,
Donor #15400, Serial #3755363, Model #V010,
Donor #15400, Serial #3755444, Model #V010,
Donor #26142, Serial #6064051, Model #V010,
Donor #26142, Serial #6064078, Model #V010,
Donor #25126, Serial #6029558, Model #V010,
Donor #25126, Serial #6029604, Model #V010,
Donor #25126, Serial #6029639, Model #V010,
Donor #25126, Serial #3029612, Model #V010,
Donor #23685, Serial #3984605, Model #V010,
Donor #23685, Serial #3984664, Model #V010,
Donor #23685, Serial #3954613, Model #V010,
Donor #23685, Serial #3984621, Model #V010,
Donor #21791, Serial #3926307, Model #V010,
Donor #21791, Serial #3925293, Model #V010,
Donor #21791, Serial #3925315, Model #V010,
Donor #22096, Serial #3938204, Model #V010,
Donor #22096, Serial #3938212, Model #V010,
Donor #22245, Serial #3941043, Model #V010,
Donor #22245, Serial #3941035, Model #V010,
Donor #22245, Serial #3941027, Model #V010,
Donor #23303, Serial #3972496, Model #V010,
Donor #23456, Serial #3976068, Model #V010,
Donor #23456, Serial #3976041, Model #V010,
Donor #25882, Serial #6071368, Model #V010,
Donor #25882, Serial #6071376, Model #V010,
Donor #30518, Serial #6223257, Model #V010,
Donor #30518, Serial #6223249, Model #V010,
Donor #29961, Serial #6212271, Model #V010,
Donor #29961, Serial #6212247, Model #V010,
Donor #29961, Serial #2612298, Model #V010,
Donor #29961, Serial #2612263, Model #V010,
Donor #29961, Serial #2612255, Model #V010,
Donor #28093, Serial #6137385, Model #V010,
Donor #28093, Serial #6137393, Model #V010,
Donor #28093, Serial #6137377, Model #V010,
Donor #27639, Serial #6105106, Model #V010
Donor #27639, Serial #6105114, Model #V010,
Donor #27157, Serial #6089453, Model #V010,
Donor #27157, Serial #6089461, Model #V010,
Donor #27086, Serial #6113869, Model #V010,
Donor #27086, Serial #6113842, Model #V010,
Donor #26734, Serial #6090761, Model #V010,
Donor #26734, Serial #6090826, Model #V010,
Donor #26177, Serial #6070256, Model #V010,
Donor #26177, Serial #6070264, Model #V010,
Donor #26177, Serial #6070272, Model #V010,
Donor #26517, Serial #6080995, Model #V010,
Donor #26517, Serial #6081002, Model #V010,
Donor #26913, Serial #6088287, Model #V010,
Donor #26913, Serial #6088295, Model #V010,
Donor #27131, Serial #6087213, Model #V010,
Donor #27131, Serial #6087221, Model #V010,
Donor #30298, Serial #6217605, Model #V010,
Donor #30298, Serial #6217613, Model #V010,
Donor #30298, Serial #6217591, Model #V010,
Donor #30515, Serial #6222994, Model #V010,
Donor #30515, Serial #6222986, Model #V010,
Donor #31001, Serial #6244645, Model #V010,
Donor #31001, Serial #6244661, Model #V010,
Donor #31001, Serial #6244653, Model #V010,
Donor #31118, Serial #6248497, Model #V010,
Donor #31118, Serial #6248489, Model #V010,
Donor #31118, Serial #6248519, Model #V010,
Donor #31295, Serial #6254039, Model #V010,
Donor #31295, Serial #6254012, Model #V010,
Donor #33878. Serial #6329535, Model #V010,
Donor #33878. Serial #6329543, Model #V010,
Donor #25296, Serial #6035485, Model #V010,
Donor #25296, Serial #6035493, Model #V010
b) Donor #20668, Serial #4065379, Model #T030,
Donor #20668, Serial #4065344, Model #T030,
Donor #20668, Serial #4065336, Model #T030,
Donor #20668, Serial #4065352, Model #T030,
Donor #26142, Serial #4101456, Model #T030,
Donor #26142, Serial #4101472, Model #T030,
Donor #26142, Serial #4101464, Model #T030,
Donor #26142, Serial #4101448, Model #T030,
Donor #21611, Serial #4067533, Model #T030,
Donor #21611, Serial #4067649, Model #T030,
Donor #21611, Serial #4067843, Model #T030,
Donor #24135, Serial #4090594, Model #T030,
Donor #24135, Serial #4090551, Model #T030,
Donor #24135, Serial #4090578, Model #T030,
Donor #24135, Serial #4090586, Model #T030,
Donor #21611, Serial #4067526, Model #T030;
c) Donor #20668, Serial #4065298, Model #M030,
Donor #14798, Serial #4044614, Model #M030,
Donor #14493, Serial #4043707, Model #M030,
Donor #26142, Serial #4101413, Model #M030,
Donor #21611, Serial #4067568, Model #M030,
Donor #24135, Serial #4090535, Model #M030,
Donor #33286, Serial #4159438, Model #M030;
d) Donor #20668, Serial #4065271, Model #M010,
Donor #14798, Serial #4044592, Model #M010,
Donor #26142, Serial #4101391, Model #M010,
Donor #21611, Serial #4067584, Model #M010,
Donor #24135, Serial #4090519, Model #M010,
Donor #33286, Serial #4159403, Model #M010,
Donor #14493, Serial #4043723, Model #M010;
e) Donor #20668, Serial #4065328, Model #M020,
Donor #14798, Serial #4044584, Model #M020,
Donor #14493, Serial #4043715, Model #M020,
Donor #26142, Serial #4101405, Model #M020,
Donor #21611, Serial #4067576, Model #M020,
Donor #24135, Serial #4090527, Model #M020,
Donor #33286, Serial #4159411, Model #M020;
f) Donor #20668, Serial #4065328, Model #M040,
Donor #14798, Serial #4044606, Model #M040,
Donor #14493, Serial #4043693, Model #M040,
Donor #26142, Serial #4101421, Model #M040,
Donor #21611, Serial #4067541, Model #M040,
Donor #24135, Serial #4090543, Model #M040,
Donor #33286, Serial #4159446. Model #M040;
g) Donor #12456, Serial #3648311, Model #A030,
Donor #19564, Serial #3850226, Model #A030,
Donor #18904, Serial #3842061, Model #A030,
Donor #18454, Serial #3823563, Model #A030,
Donor #18438, Serial #3847438, Model #A030,
Donor #18187, Serial #3818713, Model #A030,
Donor #21691, Serial #3910687, Model #A030,
Donor #21865, Serial #3928713, Model #A030,
Donor #21892, Serial #3930858, Model #A030,
Donor #21912, Serial #3933938, Model #A030,
Donor #22346, Serial #3950611, Model #A030,
Donor #22884, Serial #3963691, Model #A030,
Donor #23367, Serial #3974553, Model #A030,
Donor #26639, Serial #6086039, Model #A030,
Donor #26262, Serial #6066216, Model #A030,
Donor #27053, Serial #6100546, Model #A030,
Donor #28558, Serial #6154476, Model #A030,
Donor #30308, Serial #6218873, Model #A030,
Donor #20924, Serial #6241565, Model #A030,
Donor #32982, Serial #6953638, Model #A030,
Donor #33878, Serial #6328245, Model #A030,
Donor #31482, Serial #6261442, Model #A030,
Donor #21863, Serial #3928748, Model #A030,
Donor #25751, Serial #6048293, Model #A030,
Donor #23456, Serial #3986033, Model #A030,
Donor #23456, Serial #3976025, Model #A030;
h) Donor #21791, Serial #3925285, Model #PH00,
Donor #21791, Serial #3925277, Model #PH00,
Donor #25882, Serial #6071341, Model #PH00,
Donor #26517, Serial #6081029, Model #PH00,
Donor #26517, Serial #6081037, Model #PH00,
Donor #26913, Serial #6088414, Model #PH00,
Donor #31721, Serial #6270425, Model #PH00,
Donor #32591, Serial #6301142, Model #PH00,
Donor #20170, Serial #3893618, Model #PH00,
Donor #20170, Serial #3893596, Model #PH00;
i) Donor #12456, Serial #3648303, Model #A010,
Donor #18854, Serial #3843726, Model #A010,
Donor #18170, Serial #3817121, Model #A010,
Donor #13690, Serial #3679209, Model #A010,
Donor #10709, Serial #3604349, Model #A010,
Donor #27887, Serial #6129285, Model #A010;
j) Donor #22346, Serial #3950603, Model #A020,
Donor #22286, Serial #6962556, Model #A020;
k) Donor #24135, Serial #4090608, Model #T010,
Donor #24135, Serial #4090616, Model #T010,
Donor #33286, Serial #4159543, Model #T010,
Donor #33286, Serial #4159535, Model #T010;
l) Donor #33286, Serial #4159489, Model #T050,
Donor #33286, Serial #4159497, Model #T050;
m) Donor #33286, Serial #4159519, Model #T070,
Donor #33286, Serial #4159527, Model #T070;
n) Donor #29961, Serial #6212212, Model #V061,
Donor #31295, Serial #6254055, Model #V061;
o) Donor #29961, Serial #6212239, Model #V060,
Donor #28093, Serial #6137415, Model #V060,
Donor #28093, Serial #6137407, Model #V060,
Donor #27157, Serial #6089445, Model #V060,
Donor #27157, Serial #6089437, Model #V060,
Donor #27639, Serial #6105203, Model #V060,
Donor #27639, Serial #6105211, Model #V060,
Donor #26734, Serial #6090788, Model #V060,
Donor #26734, Serial #6090664, Model #V060,
Donor #26177, Serial #6070221, Model #V060,
Donor #26177, Serial #2070248, Model #V060,
Donor #30515, Serial #6223001, Model #V060,
Donor #30515, Serial #6223028, Model #V060,
Donor #31118, Serial #6248527, Model #V060,
Donor #31118, Serial #6248535, Model #V060,
Donor #31295, Serial #6254047, Model #V060,
Donor #33878, Serial #6329519, Model #V060,
Donor #33878, Serial #6329527, Model #V060;
p) Donor #26912, Serial #6088201, Model #PM00,
Donor #26927, Serial #6103782, Model #PM00,
Donor #26927, Serial #6103804, Model #PM00;
q) Donor #27027, Serial #6099696, Model #A015;
r) Donor #28542, Serial #6153844, Model #P020;
s) Donor #23787, Serial #3987922, Model #P010,
Donor #26913, Serial #6088422, Model #P010,
Donor #26914, Serial #6088589, Model #P010,
Donor #30298, Serial #6217834, Model #P010;
t) Donor #33286, Serial #4159454, Model #T020,
Donor #33286, Serial #4159462, Model #T020.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letters starting April, 2003. Firm
initiated recall is ongoing.
REASON
Various tissues for transplant, which were collected from donors
who may not have been properly evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 123 units;
b) 16 units;
c) 7 units;
d) 7 units;
e) 7 units;
f) 7 units;
g) 26 units;
h) 10 units;
i) 6 units;
j) 2 units;
k) 4 units;
l) 2 units;
m) 2 units;
n) 2 units;
o) 18 units;
p) 3 units;
q) 1 unit;
r) 1 unit;
s) 4 units;
t) 2 units
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1837-3.
CODE
Unit 41GP52240.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone
on July 6, 2001. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet
the requirement for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1840-3;
b) Fresh Frozen Plasma. Recall # B-1841-3;
c) Recovered Plasma. Recall # B-1842-3.
CODE
a) 2908064, 2916183, 6138159, 2904253, 2918561, 2904254,
6138166, 2937712;
b) 2908064, 2916183, 6138159, 2904253, 2937712, 6138166;
c) 2918561, 2904254;
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 21, 2002,
and December 6, 2002, and by facsimile dated December 6, 2002. Firm
initiated recall is complete.
REASON
Blood products, corresponding to platelets that were implicated
in a transfusion reaction and were possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
TX and Switzerland.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1843-3.
CODE
Unit 41FP37775.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by letter dated
June 18, 2002. Firm initiated recall is complete.
REASON
Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Platelets. Recall # B-1844-3.
CODE
Units 4502112, 4504651.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated
April 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on living
in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets Pheresis Leukoreduced. Recall # B-1846-3.
CODE
Unit 6139736.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated March 24, 2003. Firm
initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin
within three days of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1847-3.
CODE
Unit 6186087.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on January 22, 2003,
and by letter dated January 27, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1848-3;
b) Platelets. Recall # B-1849-3.
CODE
a) and b) Unit 2896349.
RECALLING FIRM/MANUFACTURER
Carter-BloodCare, Bedford, TX, by telephone on October 16, 2002.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled
to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1850-3;
b) Platelets. Recall # B-1851-3.
CODE
a) and b) Unit 6167155.
RECALLING FIRM/MANUFACTURER
Carter-BloodCare, Bedford, TX, by telephone on January 27, 2003,
and by letter dated February 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a recent
history of mononucleosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets. Recall # B-1852-3.
CODE
Unit 4250244.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on May
14, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised
the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1853-3;
b) Platelets. Recall # B-1854-3.
CODE
a) and b) Unit 4442599.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on March
26, 2003, and by telephone on March 27, 2003. Firm initiated recall
is complete.
REASON
Blood products, which were collected from a donor who had traveled
to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1855-3.
CODE
Unit 41GE67282.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone
on December 4, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised
the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1856-3;
b) Recovered Plasma. Recall # B-1857-3.
CODE
a) and b) Unit 41FL92517.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone,
facsimile, and/or letter on May 22, 2001. Firm initiated recall
is complete.
REASON
Blood products, which were collected in a manner that may have compromised
the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1858-3;
b) Fresh Frozen Plasma. Recall # B-1859-3.
CODE
a) and b) Unit 41GM52818.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone
on August 19, 2002, and by letter dated August 22, 2002. Firm initiated
recall is complete.
REASON
Blood products, which were collected from a donor in which the risk
factors for Creutzfeldt Jakob Disease (CJD) was not determined at
the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1860-3.
CODE
Unit 2897183.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 25, 2002.
Firm initiated recall is complete.
REASON
Blood product, which may have been prepared from Whole Blood with
an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1861-3;
b) Recovered Plasma. Recall # B-1862-3.
CODE
a) Units 4444173, 4426240;
b) Unit 4444173.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated
January 20, and 22, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to platelets that were contaminated
with Staphylococcus and implicated in an adverse reaction, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1863-3;
b) Plasma. Recall B-1864-3.
CODE
a) and b) Unit 6772042.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone and
facsimile on March 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which were prepared from Whole Blood in which the
corresponding Cryoprecipitated AHF was clotted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH and NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1824-3.
CODE
Unit 00EWID8403.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P. (Formerly Community Bio-Services),
Eau Claire, WI, by fax dated September 14, 2000. Firm initiated
recall is ongoing.
REASON
Blood Product, collected from a donor who disclosed receiving Hepatitis
B vaccine less than 48 hours before donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1825-3.
CODE
Unit 030GL23663.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by telephone
on January 14, 2003. Firm initiated recall is complete.
REASON
Blood Product, lacking assurance of proper temperature storage during
shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1835-3;
b) Cryoprecipitated AHF. Recall # B-1836-3.
CODE
a) and b) Unit 6157616.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 17, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of colitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Capture-P Ready Screen Test Kit. Recall # B-1845-3.
CODE
Lot 30895, Exp. 8/22/03;
Lot 32937, Exp. 9/5/03.
RECALLING FIRM/MANUFACTURER
Immucor, Inc, Norcross, GA, by letters dated August 11, 2003. Firm
initiated recall is complete.
REASON
Test kits, packaged with a Reactivity List that contained a typographical
error, were distributed.
VOLUME OF PRODUCT IN COMMERCE
199 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
CoaguChek brand PT Test Strips;
U.S. a) catalog number 3116247 (professional use);
b) 3116239 (patient self test);
ex-U.S. c) catalog numbers 1937642 (packaged 48 strips per box);
d) 1937634 (packaged 12 strips per box). Recall # Z-1293-03.
CODE
a) Lots 591;
b) Lot 619;
c) Lot 600; and
d) Lot 583. Extended to all lots with an expiration date of on or
before March 1, 2005.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated September
12, 2003 and September 29, 2003 and by press release on September
26, 2003. Firm initiated recall is ongoing.
REASON
Erroneous patient results: may be falsely elevated or lowered, due
to a packaging defect that allows air and moisture to enter the
sealed pouch.
VOLUME OF PRODUCT IN COMMERCE
563,628.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
BBL ™ LIM Broth, in glass slant tubes and packaged 100 tubes
per carton, catalog #296266. Recall # Z-1294-03.
CODE
Lot numbers: 3129508 exp 1/30/04; 3129509 exp 2/3/04; 3129506 exp
2/3/04; 3129512 exp 2/3/04.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by letter on August 11,
2003. Firm initiated recall is ongoing.
REASON
Broth for growing selective bacteria may fail to inhibit overgrowth
of gram negative microorganisms resulting in the inability to isolate
Group B Streptococci.
VOLUME OF PRODUCT IN COMMERCE
860 cartons.
DISTRIBUTION
Canada and Europe.
_______________________________
PRODUCT
a) CryoValve, Aortic & Conduit. Donor #69884, Model #AV00.
Recall # Z-1996-03;
b) CryoValve, Pulmonary Valve & Conduit. Donor #69884, Model
#PV00.Recall # Z-1997-03.
CODE
a) Serial #8062335;
b) Serial #8062341.
RECALLING FIRM/MANUFACTURER
Cryolife Inc., Kennesaw, GA, by letter on September 10, 2003 and
September 12, 2003. Firm initiated recall is ongoing.
REASON
Firm received additional information from the procurement agency
indicating that the donor’s serological test sample may have
been sufficiently diluted by transfusion/infusion to invalidate
the HIV and Hepatitis B and C screening test results.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and MN.
_______________________________
PRODUCT
Immulite 2000. Immunoassay system. Software version 2.6 was to be
uploaded on systems running 2.5b software. Recall # Z-1138-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
DPC Cirrus, Flanders, NJ, by Recall Technical Bulletins on June
13, 2003. Firm initiated recall is complete.
REASON
Version 2.6 software was released however, it will not properly
handle adjustment slopes.
VOLUME OF PRODUCT IN COMMERCE
434 upgrades.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Neonatal GALT Test Kit, 4800 assays per kit, catalog No. NG-4100.
Recall # Z-1139-03.
CODE
Lot #164738.
RECALLING FIRM/MANUFACTURER
PerkinElmer Life Sciences Inc., Norton, OH, by telephone and fax
on June 27, 2003 and July 1, 2003. Firm initiated recall is ongoing.
REASON
The kits are producing lower values than expected, which may result
in an increase of false positive test results.
VOLUME OF PRODUCT IN COMMERCE
79.
DISTRIBUTION
AL, CT, AZ, CO, FL, IN, LA, MO, NJ, and OH.
____________________________
PRODUCT
Anti-dsDNA (1251) Radiobinding Assay Kit. For In-Vitro Diagnostic
Use Catalog Number: NEA 103. Recall # Z-1140-03.
CODE
Lot Number 181578.
RECALLING FIRM/MANUFACTURER
Perkinelmer Life Sciences, Inc., Boston, MA, by telephone on July
21, 2003 and by letter on July 25, 2003. Firm initiated recall is
ongoing.
REASON
Product’s outer carton label was labeled with an extended
expiration date.
VOLUME OF PRODUCT IN COMMERCE
69 kits.
DISTRIBUTION
CA, PA, IN, MO, and Switzerland.
_______________________________
PRODUCT
On-Site Alcohol IVD A single use enzymatic assay for qualitative
detection of alcohol in urine or saliva. Catalog numbers: 47464,
Roche Diagnostics Label A305-02 Varian, Inc. label. Recall # Z-1202-03.
CODE
All kits on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Varian, Inc., Lake Forest, CA, by letter on July 18, 2003. Firm
initiated recall is ongoing.
REASON
Stability in question.
VOLUME OF PRODUCT IN COMMERCE
11,847 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Exactech Tibial Augmentation Block Trial Size 0,
Tibial Augment block Trial, Catalog # 205-60-05,
Tibial Augment Block Trial, Catalog # 205-60-08;
b) Exactech Tibial Tray Trial size 1 Delta, Catalog # 201-70-81;
c) Exactech Trapezoid Tray Trial size 1 Delta, Catalog # 205-70-
81.
Recall # Z-1211-03.
CODE
a) Lot #’s 4786-001 and 6509-001,
Lot #’s 4786-002 and 6509-002;
b) Lot #’s 4580-002, 6449-002 & 09861014;
c) Lot #’s 4603-002 & 6449-013.
RECALLING FIRM/MANUFACTURER
Rxachech, Inc., Gainesville, FL, by letter dated July 31, 2003.
Firm initiated recall is ongoing.
REASON
Misalignment of the fixation holes between the tibial augment block
trials and the corresponding tibial tray trials and trapezoid tray
trials. The misalignment of the pin fixation holes only creates
an issue when augmentation is used.
VOLUME OF PRODUCT IN COMMERCE
169.
DISTRIBUTION
Nationwide, Spain, Japan and China.
_______________________________
PRODUCT
Triton MP-1 Traction Unit. Model/Catalogue Nos.: 7961 (120 Volt)
and 7963 (220 Volt). Recall # Z-1215-03.
CODE
Serial Numbers: 4231 - 4246, 6806 - 6809, 6815, 6818 - 6819, 6824,
6851, 6856 - 6859, 6863, 6870 - 6873, 6878 - 6919, 6921 - 6958.
RECALLING FIRM/MANUFACTURER
Chattanooga Corp., Hixson, TN, by telephone and email on May 30,
2003. Firm initiated recall is ongoing.
REASON
Product contains an improper bracket for the transducer.
VOLUME OF PRODUCT IN COMMERCE
96.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan
Shaped Brest Implant Saline Filled BIOCELL textured. Recall # Z-1216-03.
CODE
27-168391, 27-363170LF.
RECALLING FIRM/MANUFACTURER
Inamed Corp, Goleta, CA, by telephone on August 1, 2003. Firm initiated
recall is complete.
REASON
Labeling mix-up.
VOLUME OF PRODUCT IN COMMERCE
4 implants.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Immulite 2000 H. pylori IgG Kit (L2KHQ6, 600 test size kit). Recall
# Z-1219-03.
CODE
Lot 118.
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp., Los Angeles, CA, by fax on July 31, 2003.
Firm initiated recall is ongoing.
REASON
Kits had parts in them that did not belong in the kit.
VOLUME OF PRODUCT IN COMMERCE
339 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each
containing 60 slides for a total of 300 tests per box *** REF
170 7801 *** (NOTE: product has an 18 month shelf life.)
Recall # Z-1224-03;
b) Vitros Chemistry***GLU (glucose) DT Slides per box***CAT 153
2316*** (NOTE: product has a 24-month shelf life.)
Recall # Z-1225-03.
CODE
a) All lots with an expiration date of 1 December 2004 and
earlier.
b) All lots with an expiration date of 1 June 2005 and earlier.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated between
July 28, 2003 and August 11, 2003. Firm initiated recall is ongoing.
REASON
Results of glucose measurements on sodium fluoride/potassium oxalate
specimens can be negatively biased when using Vitros GLU and GLU
DT slides stored in the refrigerator. GLU slides are processed by
high volume chemistry systems typically used in hospital laboratories.
VOLUME OF PRODUCT IN COMMERCE
a) 487,912;
b) 210,050.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Quick Care Starting Solution. The product is used for cleaning and
disinfection of soft (hydrophilic) contact lenses. Recall # Z-1234-03.
CODE
Lot No. 1278080, exp. date 5/2/2004.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corp, Duluth, GA, by letter on August 13, 2003. Firm
initiated recall is ongoing.
REASON
Investigation has determined that the concentration of the isopropyl
alcohol (IPA) decreased over time and may fall below specifications
prior to reaching the expiration date.
VOLUME OF PRODUCT IN COMMERCE
2,136 units.
DISTRIBUTION
CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI.
_______________________________
PRODUCT
Critikon brand Adult, DURA-CUF, product code 2790, used as an arm
cuff in association with a blood pressure monitor. Recall # Z-1236-03.
CODE
Lot number 2290.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, FL, by letter
and telephone on October 24, 2000. Firm initiated recall is complete.
REASON
Incorrect male connector attached to tubing preventing the correct
connection of blood pressure cuff.
VOLUME OF PRODUCT IN COMMERCE
235 cuffs in 47 cartons.
DISTRIBUTION
Nationwide and Japan.
_______________________________
PRODUCT
Infant reusable blood pressure cuffs, one tube, male slip luer connector,
P/N 2930, labeled in part: ***Reusable Blood Pressure Cuffs Infant
50 Cuffs REF 008-0625-00, Assembled in Mexico***. Recall # Z-1237-03.
CODE
Lot 0601.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, FL, by telephone
and letter on March 7, 2001. Firm initiated recall is complete.
REASON
Wrong connector attached to blood pressure cuff.
VOLUME OF PRODUCT IN COMMERCE
100.
DISTRIBUTION
OR.
_______________________________
PRODUCT
a) Simplastin® L, Prothrombin Time test, 10 vials (20 ml each),
Product Number 259553. Recall # Z-1238-03;
b) MDA® Simplastin® L, Product number 252555, 10 vials,
40 ml ea
(400 test each). Recall # Z-1239-03.
CODE
a) Lot # 161642, 161643 and 161690;
b) Lot # 500065, 500066 and 500067.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on July 31, 2003. Firm initiated
recall is ongoing.
REASON
Complaints of prolonged clot times.
VOLUME OF PRODUCT IN COMMERCE
1,546 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Quantum TTC Biliary Ballon Dilator. Recall # Z-1292-03.
CODE
W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960,
W1777449.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC, by letter on September
15, 2003. Form initiated recall is ongoing.
REASON
The product was labeled ‘esophageal’, but contained
a ‘biliary’ ballon.
VOLUME OF PRODUCT IN COMMERCE
127 devices.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Eu-Tec Nutrition Easi Start, Medicated, A Complete Prestarter
Feed for Pigs, containing 30 g/ton tiamulin hydrogen fumerate
and 400 g/ton chlortetracycline, packaged in 50-lb. bags.
Recall # V-321-3;
b) SBD Prestarter 1 Medicated Swine Pellets, containing 35 g/ton
tiamulin hydrogen fumarate and 400 g/ton chlortetracycline,
packaged in 50-lb. bags. Recall # V-322-3;
c) Suidae Technology Weaner Stage III Pellets, Medicated (DEN-
CTC), A Complete Starter for Pigs, containing 35 g/ton tiamulin
hydrogen fumarate and 400 g/ton chlortetracycline, packaged in
50-lb. bags. Recall # V-323-3;
d) Premium Weaner Mecadox, Medicated, A Complete Prestarter Feed
for Pigs, containing 50 g/ton carbadox, packaged in 50-lb.
bags. Recall # V-324-3;
e) Premium Starter Mecadox, Medicated, for starter pigs weighing
10 to 15 pounds, containing 50 g/ton carbadox, packaged in 50-
lb. bags. Recall # V-325-3;
f) Premium Starter Neo300, Medicated, A Complete Prestarter for
Pigs, containing 300 g/ton neomycin, packaged in 50-lb. bags.
Recall # V-326-3;
g) Eu-Tec Nutrition Vital Medicated, A Complete Starter Feed for
Pigs, containing 35 g/ton tiamulin hydrogen fumarate and 400
g/ton chlortetracycline, packaged in 50-lb. bags.
Recall # V-327-3;
h) McNess Livestock Nutrition Start 160 DG+ Swine Pellets,
Medicated, A Complete Prestarter Feed for Pigs, containing 35
g/ton tiamulin hydrogen fumarate and 400 g/ton
chlortetracycline, packaged in 50-lb. bags. Recall # V-328-3;
i) McNess Livestock Nutrition Start 175 DG+ Swine Pellets,
Medicated, containing 35 g/ton tiamulin hydrogen fumarate and
400 g/ton chlortetracycline, packaged in 50-lb. bags.
Recall # V-329-3;
j) Eu-Tec Nutrition Vital Medicated, A Complete Starter Feed for
Pigs, containing 181 g/ton tilmicosin, packaged in 50-lb. bags.
Recall # V-330-3;
k) FAC 12-16, Medicated, A Complete Starter Feed for Pigs,
containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton
chlortetracycline, packaged in 50-lb. bags. Recall # V-331-3;
l) FAC 16-22, Medicated, A Complete Starter Feed for Pigs,
containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton
chlortetracycline, packaged in 50-lb. bags. Recall # V-332-3;
m) FAC 16-22, Medicated, A Complete Starter Feed for Pigs,
containing 100 g/ton oxytetracycline and 200 g/ton neomycin
sulfate, packaged in 50-lb. bags. Recall # V-333-3;
n) FAC 16-22, Medicated, A Complete Starter Feed for Pigs,
containing 50 g/ton carbadox, packaged in 50-lb. bags.
Recall # V-334-3;
o) Alpha Starter Swine Pellets-Medicated, A Complete Prestarter
Feed for Pigs, containing 50 g/ton carbadox, packaged in 50-lb.
bags. Recall # V-335-3;
p) Beta Starter Swine Pellets-Medicated, A Complete Prestarter
Feed for Pigs, containing 50 g/ton carbadox, packaged in 50-lb.
bags. Recall # V-336-3;
q) Gamma Starter Swine Pellets-Medicated, A Complete Prestarter
Feed for Pigs, containing 55 g/ton carbadox, packaged in 50-lb.
bags. Recall # V-337-3;
r) Wean Assure Swine Pellets-Medicated, A Complete Prestarter Feed
for Pigs, containing 181 g/ton tilmicosin, distributed in
1,500-2,000 lb. totes. Recall # V-338-3;
s) Wean Assure Swine Pellets-Medicated, A Complete Prestarter Feed
for Pigs, containing 50 g/ton carbadox, distributed in 1,500-
2,000 lb. totes. Recall # V-339-3;
t) TP-1 Swine Pellets, Medicated, A Complete Starter Feed for
Pigs, containing 250 g/ton neomycin sulfate, packaged in 50-lb.
bags. Recall # V-340-3;
u) TP-2 Swine Pellets, Medicated, A Complete Starter Feed for
Pigs, containing 250 g/ton neomycin sulfate, packaged in 50-lb.
bags. Recall # V-341-3.
CODE
a) 378-17;
b) 350-1 thru 350-14; 351-9 thru 351-10; 355-1 thru 355-5; 358-1;
359-1 thru 359-11; 362-5 thru 365-14; 366-6 thru 366-15;
369-3 thru 369-13; 375-4 thru 375-13; 379-6 thru 379-10;
382-3 thru 382-5;
c) 356-8 thru 356-10;
d) 351-4 thru 351-8; 370-8; 376-8 thru 376-9; 377-1; 391-5;
e) 372-3 thru 372-12; 384-2; 390-8 thru 390-10;
f) 384-1;
g) 361-3 thru 361-4;
h) 355-8;
i) 355-6 thru 355-8; 390-5 thru 390-6;
j) 359-12;
k) 349-2 thru 349-4; 363-1;
l) 349-5 thru 349-6; 363-2 thru 363-4;
m) 349-7;
n) 349-8 thru 349-10; 349-11 thru 349-12; 363-5 thru 363-9;
363-10;
o) 370-5 thru 370-7; 384-3 thru 384-7;
p) 389-1 thru 389-5;
q) 365-7 thru 365-10;
r) 368-1 thru 368-3;
s) 369-16 thru 369-17; 375-1 thru 375-3; 400-3 thru 400-4;
424-7 thru 424-12; 425-1 thru 425-2;
t) 357-1 thru 357-2;
u) 368-11.
RECALLING FIRM/MANUFACTURER
Eu-Tec Nutrition Inc., Maquoketa, IA, by letters dated May 5, 2003.
FDA initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier
that contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
Between 188-358 tons.
DISTRIBUTION
IL, KS, IA and MN.
END OF ENFORCEMENT REPORT FOR OCTOBER 15, 2003
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