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.
_______________________________
PRODUCT
Sodium Nitroprusside Injection, 50 mg/2mL single dose vial, For Intravenous
Infusion Only, Rx only. Baxter Mfd. for an affiliate of Baxter Healthcare Corp.,
Deerfield, IL. Recall # D-319-3.
CODE
00K113, exp 08/03;
00N107, exp 10/03; 00S110, exp 12/03; 01B117, exp 02/04; 01H101, exp 06/04;
02A127, exp 01/05; 02C112, exp 03/05; 02E104, exp 05/05; 03C119, exp 03/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare
Anesthesia and Critical Care, New Providence, NJ, by letter on July 31, 2003.
Manufacturer: Gensia Sicor Pharmaceuticals, Inc, Irvine, CA. Firm initiated
recall is ongoing.
REASON
Particulates .
VOLUME
OF PRODUCT IN COMMERCE
1,146,805 vials.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Kaletra Capsules (lopinavir/ritonavir) capsules, Each soft gelatin capsule contains:
Iopinavir 133.3mg, ritonavir 33.3mg, 180 Capsules bottles, Rx only, Abbott Laboratories,
North Chicago, IL. Recall # D-320- 3.
CODE
Lot No.
852072E25, Expiration Date June 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Morris Dickson, Shreveport, LA, by telephone on August 1, 2003.
Manufacturer: Unknown. Firm initiated recall is ongoing.
REASON
Counterfeit; bottles labeled as containing Kaletra Capsules may contain Kaletra
Capsules and/or Agenerase Capsules or a mix of both, as well as, bottles of
Kaletra Capsules have been repackaged/relabeled by an unknown source with an
extended expiration date/counterfeit lot number.
VOLUME OF PRODUCT
IN COMMERCE
58 bottles of 180 capsules.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol), 16.2 g. canister, 104
metered actuations, FOR ORAL INHALATION ONLY WITH ACCOMPANYING MOUTHPIECE. Mfd.
for Aventis Pharmaceuticals Respiratory Products, Bridgewater, NJ. Recall #
D-330-3.
CODE
A30007A, Exp. Jan 2005.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Aventis Pharmaceuticals, Inc.,
Kansas City, MO, by letter dated August 7, 2003.
Manufacturer: Fisons Limited,
Holmes Chapel CW488E, Great Britain. Firm initiated recall is ongoing.
REASON
Container Defect: Misplaced side holes on metering valve stems causing a lower
dosage delivery to patient.
VOLUME OF PRODUCT IN COMMERCE
14,111 canisters.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Mylanta Antacid
Anti-Gas (Aluminum Hydroxide equivalent to dried gel, USP 200 mg, Magnesium
Hydroxide 200 mg, and Simethicone 20 mg) 5 Fl Oz (150ml) bottles. Recall # D-307-3.
CODE
Lot number HDF041.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Merck, Fort Washington, PA, by letters mailed
on June 30, 2003.
Manufacturer: Johnson & Johnson Merck, Lancaster, PA.
Firm initiated recall is ongoing.
REASON
Defective
container, tamper evident cap does not engage properly. VOLUME OF PRODUCT
IN COMMERCE
24,360 bottles.
DISTRIBUTION
Nationwide, Trinidad and Tobago.
_______________________________
PRODUCT
Zemuron Injection, (rocuronium bromide) 10 mg/mL, For IV use only, professional
sample of 6X5mL vials, 5mL and 10mL multiple dose vials. Recall # D-310-3.
CODE
Packaged Lot Numbers: 2442902450, exp. July 2004;
2453002450, exp. July 2004; 2463102450, exp. July 2004; 0583102450, exp. July
2004; 0593302450, exp. July 2004; 2483702450, exp. August 2004; 2493702450,
exp. August 2004; 0023702450, exp. August 2004; 2513802450, exp. August 2004;
2623802450, exp. August 2004; 0634002450, exp. August 2004; 0644002450, exp.
August 2004; Packaged Lot Numbers: 1483402450, exp. August 2004; 1493502450
exp. August 2004; 1503602450, exp. August 2004. The packaged lot number has
an additional three digit packaging before the manufactured lot number.
RECALLING FIRM/MANUFACTURER
Organon, Inc., West Orange,
NJ, by letters on July 1, 2003. FDA initiated recall is ongoing.
REASON
Vials may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE
1,582,420 vials.
DISTRIBUTION
Nationwide and Canada.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS – CLASS II
_______________________________
PRODUCT
Platelet Pheresis.
Recall # B-1616-3.
CODE
Unit M48122.
RECALLING
FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone
on October 9, 2001. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirements,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1633-3.
CODE
Unit 03LX19619.
RECALLING FIRM/MANUFACTURER
American
Red Cross Blood Service, Southern Region, Atlanta, GA, by fax on October 18,
2002. Firm initiated recall is complete.
REASON
Blood
product, collected from an ineligible donor due to a history of travel to an
area considered at increased risk of exposure to new variant Creutzfeldt-Jakob
Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1681-3;
b) Platelets.
Recall # B-1682-3;
c) Fresh Frozen Plasma. Recall # B-1683-3;
d) Recovered
Plasma. Recall # B-1684-3.
CODE
a) and d) Unit FG64742;
b) and c) Unit FK70653.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., DBA Rhode Island Blood Center, Providence,
RI, by telephone on April 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NY, and RI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall
# B-1685-3;
b) Platelets, Leukocytes Reduced. Recall # B-1686-3.
CODE
a) and b) FJ97316.
RECALLING FIRM/MANUFACTURER
Healthcare
Provider Services, Inc., DBA Rhode Island Blood Center, Providence, RI, by telephone
on January 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
RI.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1715-3.
CODE
Unit 1954266.
RECALLING FIRM/MANUFACTURER
Central Kentucky
Blood Center, Inc., Lexington, KY, by facsimile dated June 27, 2003. Firm initiated
recall is complete.
REASON
Blood product, collected
from a donor who traveled to an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall
# B-1724-3;
b) Platelets. Recall # B-1725-3;
c) Plasma. Recall # B-1726-3.
CODE
a), b), and c) Unit # 53FC23771.
RECALLING
FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake
and Potomac Region, Baltimore, MD, by telephone on April 21, 2003, and by letter
on April 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of medication
with the drug Acyclovir, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
3 units.
DISTRIBUTION
MD and
Washington, D.C.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS – CLASS III
_______________________________
PRODUCT
Red Blood
Cells Leukocytes Removed. Recall # B-1739-3.
CODE
Unit
numbers 20Q12582 and 20M24110.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise,
ID, by letter on July 5, 2002.
Manufacturer: The American National Red
Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red
Blood Cells, Deglycerolized. Recall # B-1746-3.
CODE
Unit number 40LC14524.
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, Peoria, IL, by telephone on April 23,
2003, and by letter dated June 30, 2003. Firm initiated recall is complete.
REASON
Red Cells, which exceeded the firm's specifications
for free hemoglobin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1755-3.
CODE
Unit number 4001301.
RECALLING FIRM/MANUFACTURER
Community
Blood Bank of Erie County, Erie, PA, by telephone on October 30, 2001. Firm
initiated recall is complete.
REASON
Blood product,
labeled with an incorrect expiration date, was distributed.
VOLUME
OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Source
Plasma. Recall # B-1758-3.
CODE
Unit number 90472657.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services,
Inc., Memphis, TN, by letter on December 20, 2002. Firm initiated recall is
complete.
REASON
Blood product, collected from a donor
that did not answer the medical history questions concerning behavior known
to increase risk of infection with the human immunodeficiency virus (HIV), was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1759-3.
CODE
Unit number 91448033.
RECALLING FIRM/MANUFACTURER
Plasma
Biological Services, Inc., Memphis, TN, by letter on December 30, 2002. Firm
initiated recall is complete.
REASON
Blood product,
collected from a donor that did not answer the medical history questions concerning
behavior known to increase risk of infection with the human immunodeficiency
virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1760-3.
CODE
Unit number 90474064.
RECALLING FIRM/MANUFACTURER
Plasma
Biological Services, Inc., Memphis, TN, by letter on December 9, 2002. Firm
initiated recall is complete.
REASON
Blood product,
collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source
Plasma. Recall # B-1761-3.
CODE
Unit number KP80346.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services,
Inc., Memphis, TN, by letter on January 6, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated
body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Platelets. Recall # B-1762-3.
CODE
Unit number K16779.
RECALLING FIRM/MANUFACTURER
Virginia
Blood Services, Richmond, VA, by telephone on April 18, 2003. Firm initiated
recall is complete.
REASON
Blood product that was lipemic
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1766-3.
CODE
Unit number 76269639.
RECALLING FIRM/MANUFACTURER
Plasma
Biological Services, Inc., Memphis, TN, by letter on November 18, 2002. Firm
initiated recall is complete.
REASON
Blood product,
untested for viral markers, was distributed.
VOLUME OF PRODUCT IN
COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells,
Leukocytes Reduced. Recall # B-1785-3.
CODE
Unit number
15396-1876.
RECALLING FIRM/MANUFACTURER
Blood Systems,
Inc., Lubbock, TX, by telephone on January 21, 2003. Firm initiated recall is
complete.
REASON
Blood product, manufactured from a
unit of Whole Blood designated as a difficult collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red
Blood Cells. Recall # B-1786-3. CODE
Unit number 042GW00043.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Northern Ohio Region, Cleveland, OH, by telephone on June 30, 2003. Firm initiated
recall is complete.
REASON
Blood product, collected
from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets
Pheresis, Leukocytes Reduced. Recall # B-1787-3.
CODE
Unit numbers 042KP08368, 042KP08371, 042KF09363, 042KF09398, 042KW16534, 042KP08430,
042KP08487, 042KF09518, and 042KW16480.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone
on June 26, 2003, and by letter on June 30, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis incorrectly tested for platelet
count were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
OH, and MI.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1792-3.
CODE
Units 16GW11943, 16KC22833, 16KC94032, 16LS94382,
16LS92361 and 16LR51844.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter
dated February 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which was prepared greater than 8 hours after the collection
of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1794-3.
CODE
Unit number 6843948.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on April
4, 2002. Firm initiated recall is complete.
REASON
Blood product, that was not leukoreduced within the appropriate time period
after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1796-3;
b) Platelets.
Recall # B-1797-3.
CODE
a) and b) unit number 6851747.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey,
Inc, East Orange, NJ, by telephone and letter on November 5, 2002. Firm initiated
recall is complete.
REASON
Blood products, collected
from a donor with an elevated body temperature, were distributed.
VOLUME
OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Source
Plasma. Recall # B-1798-3.
CODE
Unit number 7030115824.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio,
TX, by facsimile on December 15, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated
body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
United Kingdom.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1803-3.
CODE
Unit number 6151817.
RECALLING
FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by
letter dated April 24, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not properly irradiated and had an extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
_______________________________
PRODUCT
Alumina ceramic
liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic
total hip system. Recall # Z-1186-3.
CODE
Part No.
Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846
01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846
01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576
74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580
71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575
71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578
71002846 039A100609 72003252 081A145884.
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by memo notification to distributors
on May 8, 2003 and by letter to implanting physicians on August 18, 2003. FDA
initiated recall is ongoing.
REASON
Wright Medical
commercially distributed Transcend alumina acetabular shell liners lacking the
required process validation.
VOLUME OF PRODUCT IN COMMERCE
133
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Gyroscan ACS-NT system. Recall # Z-1199-03;
b) Gyroscan NT-Intera 1.5T. Recall # Z-1200-03;
c) Gyroscan 1.5T Intera.
Recall # Z-1201-03.
CODE
X1753, X1412, X1595, X1662,
102718, X1757, X1693, X1523, X1740, X1742, 86293, 101206, 86292, X0717, X1602,
X1563, X1670, X1648, X1582, 10009, 10353, 86280, 13057, 13056, 4139, 87605,
84700, 86968, 10082, 87604, 86082, 101111, 84899, 87183, 87161, 87146, 86020,
87135, 86121, 86080, 101608, X0083, 87148, 87145, 83306, 83303, 86184, 86147,
84478, 87188, X1759, 86559, 85685, 102095, 83804, 100460, 85433, 83802, 82678,
85119, 83946, 84433, 86019, 83301, 84861, 84860, 87527, 84820, 100786, 84477,
100785, 86083, 101072, 100459, 83325, 84887, 86056, 87147, 83396, 86596, 85684,
62832, 85500, 85688, 86406, 86411, 100916, 85422, 100469, 85686, 86407, 87310,
87309, 86595, 85139, 85172, 63046, 101408, 85141, 86335, 86317, 87033, 85157,
101165, 38317, 86334, 47189,86287, 86288, 101429, 87053.
RECALLING
FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter
on May 2, 2002. Firm initiated recall is complete.
REASON
Patient burns related to high SAR levels and the combined use of Synergy Body
Coil and synergy Flex-M coil.
VOLUME OF PRODUCT IN COMMERCE
112.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Diagnost 94. Recall # Z-1203-03;
b)
Multidiagnost 96. Recall # Z-1204-03;
c) Multidiagnost 97. Recall # Z-1205-03.
CODE
The firm utilizes a site number specific to each unit:
a) 26018, 62634, 62635, 38507;
b) 17197, 17368, 17325, 76449, 17247,
17339, 17304, 13444, 6616, 6558, 6559, 6426, 6539, 6541, 6583, 35366, 37859,
31000, 67642, 62363, 62362, 62278, 62300, 25769, 25901, 25884, 25768, 25900,
25888, 25834, 25967, 25710, 25907, 62279, 62310, 62403, 62391, 62309, 62404,
73921, 50135, 44742, 44670, 44703, 44760, 44699, 46921, 52354;
c) X1207,
X1069, X0668, 76345, 17605, 17436, 6852, 6853, 13709, 13971, 6935, 13608, 13951,
6981, 6993, 35481, 86113, 38023, 41372, 62666, 62667, 38897, 37995, 59497, 62936,
62504, 62885, 62988, 62937, 74057, 38657, 38530, 38500, 74056, 59633, 45014,
45013, 47166, 40940.
RECALLING FIRM/MANUFACTURER
Philips
Medical Systems, Bothell, WA, by visit starting on February 20, 2002. Firm initiated
recall is complete.
REASON
Spontaneous movement of
table without input from an operator.
VOLUME OF PRODUCT IN COMMERCE
91 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
BD Blood Glucose Test strips. BD Latitude, 100
Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical
Corp, Waltham, MA, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.
Recall # Z-1221-03.
CODE
Catalog # 322002 (fifty count
packaging) Lot Number: 2064256; Catalog # 322003 (one hundred count packaging)
Lot Numbers: 2064256, 2064273, 2071280.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by letter on July 23, 2003.
Firm initiated recall is ongoing.
REASON
Test strips
may not be meeting specifications at the lower range of glucose values.
VOLUME OF PRODUCT IN COMMERCE
754,800 strips.
DISTRIBUTION
Canada.
_______________________________
PRODUCT
BVS 5000t Bi-Ventricular Support System Transport/Backup Console. Catalog Number
0050-000. Recall # Z-1222-03.
CODE
Serial Numbers:
3042, 3045-3047, 3049-3080.
RECALLING FIRM/MANUFACTURER
Abiomed, Inc., Danvers, MA, by letter on August 19, 2003. Firm initiated recall
is ongoing.
REASON
Bi-Ventricular support system may
switch to battery when primary voltage (AC) is available.
VOLUME
OF PRODUCT IN COMMERCE
36 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.
CODE
Units with software versions A.02.00 or greater.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated
recall is ongoing.
REASON
Instructions for use include
additional information on configuration for selecting Power on Lead.
VOLUME
OF PRODUCT IN COMMERCE
16,736 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03;
b) Gyroscan NT-Intera. Recall # Z-1228-03;
c) Gyroscan Intera 1.0T & 1.5T.
Recall # Z-1229-03.
CODE
a) 6808, 87145, 86595, 50426,
100214, 101131, 63045, 103171, 41391, 38189, 37996, 85119, 84433, 83876, 102571,
86121, X1577, 44876, 86368, 44793, 87011, 101572, 100916, 82507, 85500, 13606,
86147, 76475, 86235, X1663, 38380, 101111, 37929, X1412, 86280, 37941, 38134,
101608, 25924, 84418, 101138, 6947, 86292, 83044, 63046, 86293, 86406, 102095,
50309, 87355, X1348, 101976, 76919, 17533, 37911, X0038, 26178, 85443, 101946,
13056, 41377, 76320, 59428, 84861, 14134, 76480, 101780, 50430, 50430, 50378,
13275, 85139, 45016, 87183, 86559, 102614, 102616, X1374, 101206, 83041, X1664,
X1373, X1730, X1084, X1085, X1270, X1582, X1670, X1352, X1083, X1231, X1272,
X1669, X1563, X1741, X0165, X1743, X1280, X1086, X0717, X1271, X0942, X0940,
X1740, X1081, 86184, 83303, 101056, 103142, 83631, 38415, 59528, 59357, 83616,
101346, 102018, 76477, 38652, 101313, 38508, 50226, 76848, X1759, 86555, 86082,
14117, 86925, 86020, 13894, 103126, 83080, 101874, 17648, 82506, 86410, 86570,
82610, 38731, 17573, 87365, 62659, 82668, 102889, 41346, 87038, 84887, 103207,
86556, X1043, 87311, 52408, X1593, X1753, 83071, 101423, 100679, 38797, 6841,
47029, 13967, 86248, 13754, 101347, 50390, 102548, 87019, 44994, 87605, 101934,
83325, 41392, 86596, 101425, X1594, 82583, X1353, 83306, 25958, 86335, 86317,
76352, 40904, 10009, 85172, 83395, 103258, 45036, 86597, 37938, 100459, 41441,
13748, 38749, 14128, X1756, 101551, 13058, 87135, X1080, 102110, 38143, 37986,
83946, 82955, 100462, 85436, X0034, 62658, 76807, 76469, 25966, 13932, 102724,
87527, 86408, 101188, 38111, 44833, 41362, 41345, 38966, 26219, 26074, 82627,
86411, 85688, 85686, 82626, 87604, 50336, 86019, 87309, 13020, 84860, 38984,
X1668, X1602, 13334, 13338, 13948, 102004, 76847, 102003, 6840, 87188, 26149,
13947, 80335, 83802, 10367, 10409, 38345, 85684, 50412, 50411, 100463, 86409,
83804, 38257, 86056, 87033, 45071, X1163, 101162, 102194, 87161, 87146, 84899,
59707, 13413, 85141, 10432, 13977, 58023, 103064, 87018, 86558, 86236, X1693,
102137, 86148, 103143, 84820, 38441, 87062, X0054, 102718, 26150, 103116, 100460,
X1757, 82580, 100469, 38661, 86334, 101429, 76321, 101584, 103351, 41250, 85157,
44813, 86560, 82678, 85685, 14065, X1281, 82547, X1595, 41459, 85442, X1662,
41440, X1710, 38650, 101431, 86281, 101432, 83940, 86381, X0084, X1739, 47189,
87053, 38438, 86413, 100323, 10396, 76359, 76358, 17481, 17585, 17483, 17482,
82534, 100461, 86968, 83396, 10353, 86250, 86918, 100478, 83615, 101560, 41064,
13729, 101084, 47043, 17394, 13976, 14144, 84700, 87607, X1216, X1215, 13730,
13864, 100826, 50407, X1648, 17683, 13057, 13966, 87147, 82546, 38651, 86407,
59427, 84478, 84484, 87148, 59384, 59475, 103135, 62953, 86313, 59338, 83394,
59712, 86151, 86083, 62832, 83708, 87310, 26133, 82619, 87168, 87526, 87067,
83051, 101348, X1635, 103041, 102671, 102561, 83916, 38317, 103101, X0162, 84477,
26119, 100785, X1179, X1523, 86080, 85433, 38303, 38304, 86316, 44810, 40975,
83941, 45063, 50432, 101412, 87036, 102907, 45006, 102157, 101165, 101878, 85158,
47058, 41342, 13965, 73974, 86379, 41147, 84859, 102617, 101408, 83995, 83301,
38420, X1649, 86404;
b) Serial numbers listed under Gyroscan ACS-NT with
software versions R6x, R7x, R8x;
c) Serial numbers listed under Gyroscan
ACS-NT with software versions R6x, R7x, R8x.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by Field Change Orders on November 21,
2002. Firm initiated recall is complete.
REASON
Patient
burns from cables near or in contact with the patient during use.
VOLUME
OF PRODUCT IN COMMERCE
435.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 24, 2003
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