Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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October 11, 2006
06-41

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
Dried Chinese White Mushrooms packaged in a flexible plastic bag, Net wt. 142g (5 oz), Serving size 0.30 oz. (8.5g). Servings per container about 6. Product of China, UPC 6 920543 108572, Recall # F-362-6
CODE
No coding.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Korica International, Inc., Brooklyn, NY, by letters dated, August 2, 2006.
Manufacturer: UNKNOWN, China (Mainland). New York State initiated recall is complete.
REASON
The product contained undeclared sulfites (4819ppm) based on routine sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
9 cases (55 -- 5oz. bags per case)
DISTRIBUTION
NY, PA, MA, MD, and FL

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PRODUCT
Essensia Baked Potato Salad, Net Wt. 16 oz. plastic tub, 12 tubs per case; red potatoes in a creamy mayonnaise base with cheddar cheese and bacon bits; UPC 41163-42646, Recall # F-363-6
CODE
Item #: 6904882, Use by AUG 17 06 WH
RECALLING FIRM/MANUFACTURER
Chef Solutions, Wheeling, IL, by press release on August 12, 2006. Florida State initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
692 cases
DISTRIBUTION
CA, FL, ID, MT, NV, OR, UT and WA

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PRODUCT
Publix Chocolate Chip Cookie Dough, UPC 4141500703, Recall # F-367-6
CODE
17SEP06C511
RECALLING FIRM/MANUFACTURER
Recalling Firm: Publix Super Markets, Inc., Lakeland, FL, by e-mail on June 29, 2006 and by press release on June 30, 2006.
Manufacturer: Sara Lee Bakery Group, Inc., Carrollton, TX. Firm initiated recall is ongoing.
REASON
Cookie dough contains undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
347 cases/12 18 oz. packages per case
DISTRIBUTION
FL, GA, SC, AL, and TN

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PRODUCT
Fullei Fresh Alfalfa Sprouts packed in non-flexible plastic containers with a net wt of 5 oz. and in Bulk 5 lb. cartons, Recall # F-368-6
CODE/
Shipping Carton Lot #’s: 186, 188, 193, 195, 196, 200, 202, 203, 205, 207, 209, 212, 216, 223, 224; Bulk Carton Lot #’s: 186, 188, 193, 195, 196, 200, 202, 203, 205, 209, 216, 221, 224, and 226
RECALLING FIRM/MANUFACTURER
Fullei Foods, Inc., Miami, FL, by telephone and press release on August 10, 2006 and August 18, 2006. Florida State initiated recall is ongoing.
REASON
Fullei Fresh Alfalfa Sprouts, manufactured July 1 through August 18, may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,389 Shipping containers (40,668 individual containers) and 751 -- 5 lb. cartons
DISTRIBUTION
FL

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PRODUCT
Meadow Gold Hook’d On Chocolate Ice Cream, 56 oz., UPC 41191 23234, Plant code/, 4911 XX: XX, Recall # F-369-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Meadow Gold Dairies, Orem, UT, by telephone, e-mail and press release on August 21, 2006. Firm initiated recall is ongoing.
REASON
A sub-ingredient of the ice cream, brownie bits, contains eggs as an ingredient but the labeling on the finished product did not reveal the presence of eggs.
VOLUME OF PRODUCT IN COMMERCE
19,164 units
DISTRIBUTION
AZ, CO, ID, MT, NV, OR, UT, WA, and WY

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PRODUCT
Harry and David brand Chocolate Covered Pear Bites, in 8 oz. packages, Recall # F-370-6
CODE
037061
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harry & Davis, Medford, OR, by telephone and e-mail on July 17, 2006 and by press release on July 21, 2006.
Manufacturer: Marich Confectionery Co., Inc., Hollister, CA. Firm initiated recall is complete.
REASON
Some packages labeled as Chocolate Covered Pear Bites contain another product, Key Lime Cookie Bites, with undeclared egg, almonds, and wheat flour.
VOLUME OF PRODUCT IN COMMERCE
2,688 bags
DISTRIBUTION
Nationwide

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PRODUCT
Cahill’s Farm brand Cahill’s Porter Cheese, Vintage Irish Cheese with Porter, packaged in random-weight wax-covered wedges in cryovac ranging in weight between approximately 4.5 oz. -- 7 oz. , Recall # F-371-6
CODE
Sell by: 6/16/06, 6/25/06, 7/2/06, 8/17/06, 8/19/06, 8/29/06, 9/2/06, and 10/10/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Swiss-American, Inc., Saint Louis, MO, by telephone on May 10, 2006 and by press release on June 14, 2006.
Manufacturer: Cahill Farm Cheeses, Limerick, Ireland. Firm initiated recall is complete.
REASON
The cheese tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
105.71 lbs.
DISTRIBUTION
MO, IL, LA, AR and TN

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PRODUCT
Various brand name Spring mix (CC392 - Classic Choice, CG795 - Classic Green, CS305 - Classic Salad Big, CS312 - Classic Salad, CS392 - Classic, CS795 - Classic Salads, DM795 - Diam, SL795 - Sir Lancelot, TV795 - Taste of the Valley, US392 - US Fresh, VG795 - Valley Gold) in the following varieties: Asian Mix, Corex Blend, Lettuce, Lollo Rosa, Mizuna, Spring Mix, Spring Mix 20% CPK, Spring Mix 25%NR, Spring Mix Cheesecake Mix, Spring Mix N/R-N/Spin., Spring Mix No Rad, Spring Mix NoF/X-Rad, Spring Mix Retail, Spring Mix X/Rad, Tatsoi-- in Pillow pack, liner and clamshell containers, Recall # F-372-6;
Baby Spinach in various brand names (CS305 - Classic Salad Big, CS305 - Classic Spinach Big, CS312 - Classic Salad, CS795 - Classic Salads, QV795 - Queen Victoria, Taste of the Valley, VG305 - Valley Gold, VG795 - Valley Gold) in Liner and pillow pack plastic packaging, Recall # F-373-6
CODE
a) Lot ID 6204112M: Finished Pallet ID: 000025233, 000052084, 000052085, 000052086, 000052087, 000052088, 000052089, 000052090, 000052091, 000052092, 000052093, 000052094, 000052095, 000052096, 000052099, 000052100, 000052101, 000052102, 000052103, 000052104, 000052105, 000052106, 000052107, 000052108, 000052109, 000052110, 000052111, 000052114, 000052130, 000052134, 000052284, 000052285, 000052286, 000052287, 000052288, 000052289, 000052290, 000052292, 000052293, 000052294, 000052295, 000052296, 000052297, 000052298, 000052299, 000052300, 000052301, 000052302, 000052303, 000052304, 000052305, 000052307, 000052308, 000052309, 000052310, 000052311, 000052324, 000052329, 000052484, 000052486, 000052487, 000052488, 000052489, 000052490, 000052491, 000052492, 000052493, 000052494, 000052495, 000052496, 000052520, 000052522, 000052523, 000052524, 000052525, 000052526, 000052527, 000052528, 000052529, 000052530, 000052531, 000052532, 000052534, 000052535, 000052536, 000052537, 000052538, 000052539, 000052712, 000052713, 000052714, 000052715, 000052716, 000052717, 000052719, 000052721, 000052723, 000052725, 000052727, 000052729, 000052731, 000052733, 000052737, 000052739, 000052912, 000052914, 000052915, 000052916, 000052917, 000052918, 000052919, 000052920, 000052921, 000052922, 000052923, 000052924, 000052925, 000052926, 000052927, 000052928, 000052929, 000052930, 000052931, 000052932, 000052933, 000052934, 000052935, 000052936, 000052937, 000052939 , 000052954 , 000052960 , 000524851;

b) Lot ID 6204112M, Finished pallet IDs 000052112, 000052113, 000052115, 000052116, 000052117, 000052118, 000052119, 000052120, 000052121, 000052122, 000052123, 000052124, 000052125, 000052126, 000052127, 000052128, 000052131, 000052448, 000052503, 000052718, 000052720, 000052722, 000052724, 000052726, 000052728, 000052734, 000052738, 000052946, 000052947, 000052949, 000052950, 000052951, 000052952, 000052953, 000052955, 000052956, 000052957, 000052958, 000052959, 000052961, 000052962, 000052963, 000052964, 000052965, 000052966, 000052967
RECALLING FIRM/MANUFACTURER
Classic Salads, LLC, Watsonville, CA, by e-mail, telephone, letters and press release beginning on July 27, 2006. Firm initiated recall is ongoing.
REASON
Products are contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
a) 8,724 pallets totaling 53,668 units;
b) 4,847 pallets totaling 20,123 units
DISTRIBUTION
Nationwide, Canada and possibly Japan

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
a) Shaw’s Potato Salad Homestyle, Bulk and 1 lb, Recall # F-337-6;
b) Shaw’s Potato Salad red Bliss, Bulk and 1 lb, Recall # F-338-6;
c) Shaw’s Egg/Potato Salad, Bulk and 1 lb, Recall # F-339-6
CODE
Product sold prior to 7/05/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shaw’s Supermarket, Inc., West Bridgewater, MA, by e-mail on July 5, and July 7, 2006.
Manufacturer: Silver Spoon Salad Co., Inc., Chelsea, MA. Firm initiated recall is complete.
REASON
Potato salads contain plexiglass fragments.
VOLUME OF PRODUCT IN COMMERCE
34,826 lbs.
DISTRIBUTION
CT, MA, RI, ME, NH, and VT

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PRODUCT
a) Lobo brand Thai Custard Mix, Pandan Flavor, 4.2 oz., in plastic packet,
24 packets/case, labeled in dual language and further labeled in
part ***Globo Foods Ltd. *** Thailand***, Recall # F-341-6;
b) Lobo brand Thai Agar Dessert Mix, Fruits Flavor, 4 oz., plastic packet,
24 packets/case, labeled in dual language and further labeled in
part ***Globo Foods Ltd. *** Thailand***, Recall # F-342-6;
c) Lobo brand Thai Agar Dessert Mix, Flowers Flavor, 4 oz., plastic packet,
24 packets/case, labeled in dual language and further labeled in
part ***Globo Foods Ltd. *** Thailand***, Recall # F-343-6
CODE
a) 100920;
b) 100980;
c) 100970
RECALLING FIRM/MANUFACTURER
Eastland Food Corp., Columbia, MD, by letter on April 5, 2006. New York State initiated recall is complete.
REASON
a) and b) Imported food products contain certified color additives FD&C Blue No. 1
and FD&C Yellow No. 5 which are not listed in the format required
for products marketed in the US;
c) Imported food products contain certified color additives FD&C Red No. 3
which is not listed in the format required for products marketed in the US;
VOLUME OF PRODUCT IN COMMERCE
138 cases
DISTRIBUTION
Nationwide

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PRODUCT
a) Carrot Juice in 8 oz., 16 oz. and 32 oz. bottles under the following labels:
Evolution b) Harvest, Recall # F-344-6:
b) Organic Carrot Juice in 8 oz., 16 oz. and 32 oz. bottles under the
following labels: a) Evolution b) Harvest, Recall # F-345-6;
c) Carrot Celery Beet Juice in 8 oz., 16 oz. and 32 oz. bottles under
the following labels: a) Evolution b) Harvest, Recall # F-346-6;
d) Carrot Parsley Spinach Juice in 8 oz., 16 oz. and 32 oz. bottles
under the following labels: a) Evolution b) Harvest, Recall # F-347-6;
e) Incredible Vegetable Juice in 8 oz., 16 oz. and 32 oz. bottles under
the following labels: a) Evolution b) Harvest, Recall # F-348-6;
f) Organic V Juice in 8 oz., 16 oz. and 32 oz. bottles under the following
labels: a) Evolution b) Harvest, Recall # F-349-6;
g) Essential Greens Juice in 8 oz., 16 oz. and 32 oz. bottles under
the following labels: a) Evolution b) Harvest, Recall # F-350-6;
h) Watermelon Juice in 8 oz., 16 oz. and 32 oz. bottles under the
following labels: a) Evolution b) Harvest c) Trader Joe's,
Recall # F-351-6;
i) Acai Amazon Blast Antioxidant Fruit Protein Blend Juice in 8 oz.
and 16 oz. bottles under the following labels: a) Evolution b) Harvest ,
Recall # F-352-6;
j) Defense Up Juice,(a blend of juice, herbs, & vitamin C) in 8 oz. and
16 oz. bottles under the following labels: a) Trader Joe's b) Evolution,
Recall # F-353-6;
k) Evolution brand Super Green, A Juice Blend With Green Superfoods,
in 8 oz. and 16 oz. bottles, Recall # F-354-6;
l) Bee Energized, A Juice Blend with Ginseng, Ginko & Gotu in 8 oz. and
16 oz. bottles under the following labels: a) Evolution b) Harvest,
Recall # F-355-6;
m) Evolution brand Orange Juice in 8 oz., 32 oz., and 64 oz. bottles,
Recall # F-356-6;
p) Old Fashioned Lemonade in 8 oz. and 64 oz. and gallon bottles
under the following labels: a) Evolution b) Harvest, Recall # F-357-6;
o) Organic Lemonade in 8 oz., 16 oz. and 32 oz. bottles under the
following labels: a) Evolution b) Harvest, Recall # F-358-6
CODE
a), b), c), d), e), and f) Code & Expiration date:1/12;Code & Expiration date:1/12;
g), h), and i) Code & Expiration date:1/14;
j) k) l) Code & Expiration date:1/17;
m) Code & Expiration date:1/20;
n), and o) Code & Expiration date:1/23;
RECALLING FIRM/MANUFACTURER
Juice Harvest Corp., San Bernardino, CA, by letter on January 5, 2006. Firm initiated recall is ongoing.
REASON
Manufacturer failed to produce juice under requirements of Hazard Analysis and Critical Control Point (HACCP) 21 CFR Part 120.
VOLUME OF PRODUCT IN COMMERCE
4,025 units
DISTRIBUTION
CA

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PRODUCT
Raw refrigerated Escolar fillets, Recall # F-359-6
CODE
Distributed between May 1, 2006 and May 18, 2006.
RECALLING FIRM/MANUFACTURER
Worldwide Fish and Seafood’s, Inc., Minneapolis MN, by telephone beginning on May 19, 2006. Firm initiated recall is ongoing.
REASON
Product contained high levels of histamine and was associated with illnesses.
VOLUME OF PRODUCT IN COMMERCE
15 orders
DISTRIBUTION
MN

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PRODUCT
Kraft Handi-Snacks Baskin 31 Robbins Pudding -- Fudge Rocky Road, 4 cup pack, Net Wt. 14 oz., 12 4-packs per case, UPC 24000-17492, Recall # F-360-6
CODE
Best When Used By 21 JUL 07 SNT2 xx:xx CF/RR, xx:xx is the military time.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by letter, e-mail, fax or visit beginning on May 18, 2006.
Manufacturer: Kraft Foods Global, Inc., Scarborough, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Some of the shelf-stable pudding cups are spoiled due to Klebsiella pneumoniae contamination.
VOLUME OF PRODUCT IN COMMERCE
5,321 cases
DISTRIBUTION
Nationwide and PR

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PRODUCT
Nature’s Nectar * Ruby Red Grapefruit Juice Drink from Concentrate * 130% Vitamin C * Net 64 fl. oz. (2 qt) 1.89L. The product is packed in PET bottles. UPC # 4149813732, Recall # F-361-6
CODE
021607 11D followed by the time code
RECALLING FIRM/MANUFACTURER
All Juice Food & Beverage LC, Hendersonville, NC, by telephone on July 18, 2006. Firm initiated recall is ongoing.
REASON
Ruby Red Grapefruit Juice is spoiled due to Paecilomyces variotii contamination.
VOLUME OF PRODUCT IN COMMERCE
704 cases
DISTRIBUTION
TN

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PRODUCT
a) Product is 'Strawberry Cake' packed in a multi-colored and clear plastic bag.
The cardboard master carton labeled in part, 'ITEM NO. 625478***
STRAWBERRY CAKE Q'TY: 48 BAGS/ 8.8 OZ***MADE IN TAIWAN***'.
The retail unit has both foreign and English labeling. The retail unit is
rectangular in shape wrapped in a multi-colored plastic paper labeled in
part, '***STRAWBERRY CAKE***MADE IN TAIWAN***NET WT: 7.76OZ
(220g)*** FD&C RED#40***', Recall # F-364-6;
b) Product is 'Dried Sweet Potato' packed in a multi-colored and clear plastic
bag. Cardboard master carton contains both foreign English labeling. The
master carton is labeled in part, '***ASIAN TASTE***Dried Sweet Potato
(strip)***NET WEIGHT: 7oz***PRODUCT OF CHINA***Distributed By:
The retail package is a multicolored clear plastic bag containing orange-
colored dried strips of vegetable that is labeled in part, '***ASIAN TASTE***
Dried Sweet Potato***NET WEIGHT: 7OZ***, Recall # F-365-6;
c) Product is 'Honey Dew Melon Cake' packed in a multi-colored and clear
plastic bag. The cardboard master carton labeled in part, '***MADE IN
TAIWAN***ITEM NO.645479***HONEY DEW MELON CAKE Q'TY:48
BAGS/8.8OZ N.W.: 12KGS.***'. Both the master carton and retail package
has foreign and English labeling. The retail package is rectangular in shape
and wrapped in a multicolored and clear plastic bag labeled in part, '***
HONEY DEW MELON CAKE***MADE IN TAIWAN***NEW WT:7.76 OZ
(220g)*** FD & C YELLOW #5 FD & C BLUE #1***', Recall # F-366-6
CODE
a) Item no. 645478;
b) Item no. 641822;
c) Item no. 645479
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walong Marketing, Inc., Buena Park, CA, by press release and letter on June 23, 2006.
Manufacturer: Grand Western Foods, Corp., Taichung City, Taiwan, Republic of China. Firm initiated recall is ongoing.
REASON
Products contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
To be determined.
DISTRIBUTION
Nationwide

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PRODUCT
CC Brown’s Hot Fudge Sauce in 10.5 oz. jars and 2 gallon containers, Recall # F-374-6
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lawry’s Restaurant, Inc., Pasadena, CA, by telephone on July 14, 2006 and by e-mail on July 17, 2006.
Manufacturer: The Ultimate Nut Company, Inc., dba Ultimate Nut & Candy Co., Burbank, CA. Firm initiated recall is ongoing.
REASON
Hot fudge sauce may contain copper fragments.
VOLUME OF PRODUCT IN COMMERCE
2,424, 10.5 oz. jars (2 gallon containers used in restaurants only)
DISTRIBUTION
IL, TX, CA, and NV

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS IIl

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PRODUCT
Weis Quality Certified Spring Water Sodium Free 1 gallon plastic containers. Recall # F-340-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Weis Markets, Inc., Sunbury, PA, by press release on August 25, 2006. Pennsylvania State initiated recall is ongoing.
REASON
Laboratory analysis indicates bromate levels in excess of Federal limit of 10 ppb (19 ppb highest level found).
VOLUME OF PRODUCT IN COMMERCE
2,727,270 containers
DISTRIBUTION
PA, NY, NJ, MD, and VA

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PRODUCT
a) H-E-B Yellow Corn Tortillas in the following sizes: 10 ct., 30 ct. ziplock,
36 ct., 50 ct., and 80 ct. UPC Codes: 41220-88027 (10 ct.),
41220-02971 (30 ct. ziplock), 41220-88028 (36 ct.), 41220-90784 (50 ct.),
and 41220-88039 (80 ct.), Recall # F-375-6;
b) H-E-B White Corn Tortillas in the following sizes: 30 ct. ziplock, 36 ct.,
50 ct., and 80 ct. UPC Codes: 41220-76734 (30 ct. ziplock),
41220-88029 (36 ct.), 41220-57765 (50 ct.), and 41220-79556 (80 ct.),
Recall # F-376-6;
c) H-E-B Home Style Corn Tortillas in the following sizes: 12 ct. and 30 ct.
UPC Codes: 41220-58841 (12 ct.) and 41220-58742 (30 ct.), Recall # F-377-6;
d) Mi Tradicion Yellow Corn Tortillas in the following size: 36 ct.
UPC Code: 41220-18269, Recall # F-378-6;
e) Mi Tradicion White Corn Tortillas in the following sizes: 36 ct. and 90 ct.
UPC Code: 41220-18270 (36 ct.) and 41220-18273 (90 ct.), Recall # F-379-6
CODE
a), b), c), and d) All lots;
e) 'Best by Jul 19 - CAD 19 07', 'Best by Jul 20 - CAD 20 07',
'Best by Jul 21 - CAD 21 07', 'Best by Jul 22 - CAD 22 07',
and 'Best by Jul 23 - CAD 23 07'
RECALLING FIRM/MANUFACTURER
Recalling Firm: HE Butt Corporate Headquarters, San Antonio, TX, by e-mail and press release on July 13, 2006.
Manufacturer: HE Butt Distribution Center, Corpus Christi, TX. Firm initiated recall is ongoing.
REASON
Tortillas may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
72,064 packages
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system, Recall # Z-0704-06
CODE
All MiniView 6800 systems
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on April 28, 2006. Firm initiated recall is ongoing.
REASON
Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
VOLUME OF PRODUCT IN COMMERCE
534 units
DISTRIBUTION
Nationwide

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PRODUCT
a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system,
Recall # Z-1301-06;
b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06;
c) RUS Tool Version Software, Recall # Z-1303-06
CODE
a), and b) All units;
c) All versions prior to Version 7.1.43
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 14-15, 2006. Firm initiated recall is ongoing.
REASON
X-ray systems could provide output which exceeds the 20 R/minute limit.
VOLUME OF PRODUCT IN COMMERCE
11,279 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
GE Precision RX/I System, Recall # 1485-06
CODE
All units
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, LLC, Waukesha, WI, by GE Field service representative visit beginning on September 22, 2006. Firm initiated recall is ongoing.
REASON
Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv).
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide

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PRODUCT
Smith & Nephew Hip Positioning System Ref: 72200624 with System Components. Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629, Recall # Z-1514-06
CODE
Product distributed prior to May 5, 2006
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter and telephone on May 22, 2006. Firm initiated recall is ongoing.
REASON
The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide

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PRODUCT
a) Ammonia/alcohol Control Set for the quantitative determination of
ammonia/alcohol in blood. Catalog number A7504-CTL,
Recall # Z-1543-06;
b) Alcohol Reagent Set for the quantitative determination of ethyl
alcohol in serum. Imported and marketed in India. Catalog number
A7504-150-S, Recall # Z-1544-06;
c) Alcohol Standard, 100 mg/di, Catalog # A7504-STD, Recall # Z-1545-06;
d) Alcohol Control, Catalog # 7-A7504-CTL, Recall # Z-1546-06;
e) Alcohol Control, Level 1. Catalog # 7-A7504-CTL-L1, Recall # Z-1547-06;
f) Alcohol Control, Level 2. Catalog # 7-A7504-CTL-L2, Recall # Z-1548-06;
g) Alcohol Standard, Catalog # 7-A7504-STD, Recall # Z-1549-06
CODE
a), d), e), and f) Lot 522202, exp. 7/06;
b) Lot 507401;
c), and g) Lot 509102, exp. 9/06
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letters dated June 9, 2006 and June 21, 2006. Firm initiated recall is ongoing.
REASON
Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
VOLUME OF PRODUCT IN COMMERCE
699 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
GE 4 inch Anterior Cervical Post, GE Part Number: 1006385 or 1006385-NAV, (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems), Recall # Z-0001-07
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 31, 2006. Firm initiated recall is ongoing.
REASON
Weld defect -- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
VOLUME OF PRODUCT IN COMMERCE
208 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Thoratec brand TLC-11 Portable Ventricular Assist Device (VAD) Driver, Recall # Z-0004-07
CODE
All codes
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, by letters on August 26, 2006. Firm initiated recall is ongoing.
REASON
Sticky valve disk -- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Stryker Navigation System, eNite System with Dell laptop computer
model D800, Stryker # 7700-300-000, Recall # Z-0005-07;
b) Stryker Navigation System Remote Planning Station with Dell laptop
computer model D800, Stryker # 7700-010-000, Recall # Z-0006-07;
c) Stryker Navigation System, Dell Model D800 laptop computers
(only), Stryker # 7700-309-010 and 6000-200-064, Recall # Z-0007-07;
d) Stryker Navigation System, Navigation Laptop System with Dell laptop
computer model D800, Stryker # 6000-200-000, Recall # Z-0008-07
CODE
All units
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Division of Stryker Corporation, Portage, MI, by letter dated September 8, 2006. Firm initiated recall is ongoing.
REASON
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
VOLUME OF PRODUCT IN COMMERCE
218 laptops
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811,
74018813, 74018815, 74018817, Recall # Z-0009-07;
b) Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480,
71440482, 71440484, 71440486, Recall # Z-0010-07;
c) Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers:
71927102, 71927103, 71927104, 71927105, Recall # Z-0011-07
CODE
a) Catalog number 74018811 Lot Numbers: 06CM3493, 06CM03494,
06CM11279, 06CM11280, 06DM01843, 06DM01844, 06EM04235,
06EM04237, 06EM07308, 06FM11461, 06FM11462, 06GM00024,
06GM00024, 06GM00025, 06GM00026, 06GM00027, 06GM00028
Catalog number 74018813 Lot Numbers: 06CM03491, 06CM03492,
06CM03492A, 06DM09155, 06DM09156, 06DM09157, 06DM09158,
06DM12567, 06DM12568, 06DM12569, 06DM12570, 06DM12571,
06EM07309, 06EM07310, 06FM02041, 06FM02042, 06FM11464,
06FM11465, 06GM06530, 06GM06531
Catalog number 74018815 Lot Numbers 06CM03489, 06CM03490,
06CM03490A, 06CM11283, 06CM11284, 06DM01852, 06DM01853,
06DM09532, 06DM09534, 06DM09535, 06DM09536, 06FM11466,
06FM11467, 06GM00029, 06FM00030, 06GM00031, 06GM00032,
06GM06532, 06HM05954, 06HM05955, 06HM05956, 06HM05957,
06HM05958, 06HM05959
Catalog number 74018817 Lot Numbers: 06CM03486, 06CM03487,
06CM03488, 03CM03488A, 06CM12230, 06CM12231, 06DM01851,
06DM12572, 06DM12573, 06DM12574, 06DM12575, 06DM12576,
06FM11468, 06FM11469, 06GM00033, 06GM00034, 06GM00035,
06GM00036, 06GM10621;
b) Catalog Number 71440480 Lot Numbers: All lots prior to 06MM*****
Sequence, including those items with suffixes.
Catalog Numbers 71440482 Lot Numbers: All lots prior to 06MM*****
Sequence, including those items with suffixes.
Catalog Number 71440484 Lot Numbers: All lots prior to 06MM*****
Sequence, including those items with suffixes.
Catalog Number 71440486 Lot Numbers: All lots prior to 06MM*****
Sequence, including those items with suffixes;
c) Catalog Number 71927102 (Size 1-2) Lot Numbers 06AM00936,
05KM07017, 04KM18886, 04JM05040, 03FM11332, 03FM11334,
03DM01797, 02FM07372, 02CM04108, 01LM08844, 01AM16024, 00306631
Catalog Number 71927103 (Size 3-4) Lot Numbers: 06AM00937,
04LM11514, 04KM18887, 04KM12225, 04FM08554, 03FM11350,
03FM11352, 03DM01798, 02FM07387, 02CM04110, 01LM08847, 00306632
Catalog Number 71927104 (Size 5-6) Lot Numbers: 04KM15385,
04LM09224, 03FM11353, 03DM01800, 02CM04114, 01LM08850, 00306635
Catalog Number 71927105 (Size 7-8) Lot Numbers: 06AM00940,
05KM07018, 04KM18889, 04LM09225, 04FM08555, 03FM11356,
03FM11355, 03DM01803, 02CM04121, 02CM04118, 01LM08854,
01LM08852, 01HM12256, 01BM14137, 00306638
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Memphis, TN, by letter and telephone on August 29, 2006.
Manufacturer: Southeastern Technology, Inc., Murfreesboro, TN. Firm initiated recall is ongoing.
REASON
Tibial punches were not manufactured to specification and could break at the tip during use.
VOLUME OF PRODUCT IN COMMERCE
5,367 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Axis-Shield DIASTAT Anti-CCP test kit, code FCCP200, Recall # Z-0003-07
CODE
Lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09); and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8°C. The nonconforming kit component is the Negative Control (labeled 'CONTROL --'). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).
RECALLING FIRM/MANUFACTURER
Axis-Shield Diagnostics, Ltd., Dundee, Scotland, UK, by letter beginning November 11-16, 2005. Firm initiated recall is ongoing.
REASON
The preservative sodium azide used in the Kit Negative Control (part number FCOM175 was at the wrong concentration -- the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.
VOLUME OF PRODUCT IN COMMERCE
2,288 kits
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR October 11, 2006

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