October 23, 2002
02-42
_____________________________
PRODUCT
a) Owens SnackWiches Sausage,
Egg & Cheese Biscuit
(refrigerated and frozen). The frozen
is bulk pack for
food service use. Recall # F-011-3;
b) Bob Evans SnackWiches Ham &
Cheese Bagels, refrigerated.
Recall # F-012-3.
CODE
a) UPC Code: 70110-05525 Sell-by:
AMI 1261-2;
UPC Code: 70110-05425 Sell-by: April
19 BC2059;
b) UPC Code: 75900-00758 Sell-by
May 11 CC2084.
RECALLING FIRM/MANUFACTURER
Owens Country Sausage, Richardson,
TX, by press release on April 14,
2002 and by letter and telephone
on April 17, 2002. State initiated
recall is complete.
REASON
The products were found to be
contaminated with Listeria monocytogenes
by the Texas Department of Health.
VOLUME OF PRODUCT IN COMMERCE
a) #5525- 47 cases; #5425- 567
cases;
b) #758- 2cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Honey Buns under the following
labels:
4005179, Sunbeam 4.75oz, Honey Bun;
4005181, Aunt Hannah, 4.75oz Honey
Bun;
4005182, Aunt Hannah, 4.75oz Honey
Bun;
4005189, Bluebird, 4.75oz Honey Bun;
4005264, Mrs. Fresh ley's 2 pc Shipper
Display
4.75oz Honey Bun;
4005671, Mrs. Fresh ley's 4.75oz
Honey Bun;
4008779, Bluebird 4.75oz Honey Bun.
Recall # F-010-3.
CODE
Pull date October 5, 2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mrs. Smith's
Bakeries, Inc., Suwanee, GA, by letter
on or about September 25, 2002.
Manufacturer:
Mrs. Smith Bakeries/Flowers Snack
of London, LLC London, KY. Firm initiated
recall is ongoing.
REASON
The product was contaminated
with mold prior to its pull date.
VOLUME OF PRODUCT IN COMMERCE
3224 cases/48 units per case.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Testosterone Cypionate for
Injection, 200 mg/mL,
1 mL, 5 mL and 10 mL vials.
Recall # D-010-3;
b) Hyaluronidase for Injection, 25
Units/mL, 1 mL vial
(Preservative free). Recall # D-011-3;
c) Hyaluronidase for injection, 150
Units/mL, 1 mL and 5 mL
vials (preservative-free), FOR OFFICE,
CLINIC, OR
HOSPITAL USE ONLY. Recall # D-012-3;
d) Hyaluronidase for Injection 150
Units/mL, 10 mL
multi-dose vial for injection, FOR
OFFICE, CLINIC, OR
HOSPITAL USE ONLY. Recall # D-013-3;
e) Betamethasone for Injection 6
mg/mL 1 mL vial or 5 mL
multi-dose vial, For Office, Clinic,
or Hospital Use
Only. Recall # D-014-3;
f) Hydroxyprogesterone Caproate Long-acting
IM Injection,
250 mg/ml, 5 ml vial. Recall # D-015-3;
g) Furosemide for Injection, 10 mg/mL,
4 mL and 10 mL
vials. Recall # D-016-3;
h) Estrone for Injection, 5 mg/mL,
(Multiple-dose vial),
5 mL vials. Recall # D-017-3;
i) Prostaglandin E1 for Injection,
20 mcg/mL, 10 mL vials.
Recall # D-018-3;
j) Papaverine 30 mg/mL, phentolamine
0.5 mg/mL and
prostaglandin E1 10 mcg/mL for Injection,
Store in
Refrigerator, 10 ml vials. Recall
# D-019-3;
k) Corticotropin LA for Injection,
80 Units/mL, Refrigerate
Product, 5 mL vials. Recall # D-020-3;
l) Meperidine for Injection, 25 mg/mL,
1 mL vial
(preservative-free). Recall # D-021-3;
m) Meperidine for Injection, 50 mg/mL,
1 mL vial
(preservative-free). Recall # D-022-3;
n) Estradiol Cypionate/Testosterone
Cypionate for
Injection, 4mg/100 mg/mL, 10 mL Multiple-dose
vial.
Recall # D-023-3;
o) Estradiol Cypionate for Injection,
5 mg/mL, 10 mL
Multiple-dose vial. Recall # D-024-3;
p) Sodium Tetradecyl Sulfate 3% Solution
for Injection,
10 mL Multiple-dose vial. Recall
# D-025-3;
q) Triamcinolone Acetonide for Injection,
4 mg/mL, 10 mL
Multiple-dose vial, For Office, Clinic,
or Hospital
Use Only. Recall # D-026-3;
r) Phenol for Injection, 5%, 5 mL
vials. Recall # D-027-3;
s) Progesterone in Sesame Oil for
Injection, 50 mg/mL,
10 mL Multiple-dose vial. Recall
# D-028-3.
CODE
All lot codes for all products.
RECALLING FIRM/MANUFACTURER
Portage Pharmacy (aka) Innovative
Professional Services), Portage,
MI, by fax on June 17, 2002. Firm
initiated recall is complete.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
Approx. 175 vials.
DISTRIBUTION
MI.
_____________________________
PRODUCT
1) Quad Tann Pediatric Suspension,
Breckenridge
Pharmaceutical, Inc., Each 5 ml contains:
Carbetapentane Tannate 30 mg, Chlorpheniramine
Tannate 4 mg, Ephedrine Tannate 5
mg and Phenylephrine Tannate 5 mg.,
One Pint (473 mL), Rx Only, NDC 51991-815-16.
1a) Quad Tann Pediatric Suspension,
URL, One Pint (473 mL),
Each 5 ml contains: Carbetapentane
Tannate 30 mg,
Chlorpheniramine Tannate 4 mg, Ephedrine
Tannate 5 mg
and Phenylephrine Tannate 5 mg Rx
Only, NDC 0677-1793-
33. Recall # D-030-3;
2) Trionate Suspension, One Pint,(473
mL),Breckenridge
Pharmaceutical, Inc., Each 5 ml contains:
Carbetapentane Tannate 30 mg, Chlorpheniramine
Tannate 4 mg., Rx only, NDC 51991-071-16,
2a) Trionate Suspension, One Pint
(473 mL), URL, Each 5 ml
contains: Carbetapentane Tannate
30 mg, Chlorpheniramine
Tannate 4 mg, Rx Only, NDC 0677-1792-33.
Recall # D-031-3;
3) Tri Tann Pediatric Suspension,One
Pint (473 mL),
Each 5 mL contains: Phenylephrine
Tannate 5 mg, Chlorpheniramine Tannate
2 mg, Pyrilamine Tannate 12.5 mg,
Rx Only, NDC 51991-052-16. Recall
# D-032-3;
4) Duotan Suspension, Antihistamine/Decongestant,
Strawberry/Banana Flavor, 4 fl. oz.
and 16 Fl. oz.
bottles, Each 5 ml contains: Chlorpheniramine
Tannate
4.5 mg,Pseudoephedrine Tannate 75
mg, Breckenridge
Pharmaceutical, Inc., Rx Only, NDC
51991-063-16 (16 Fl.
oz), NDC 51991-063-04 (4 Fl. oz.).
Recall # D-033-3;
CODE
1) Quad Tann Pediatric :
T0907, T0929, T1023, T1102, T1208,
T1218, U0815,
U0905, U0917, U0919, U1019, U1205,
U1207, U1527, U1114.
2) Trionate Suspension :
AF004, U0620, U0828, U0820, U0823,
U0831, U0908, U0911,
U0913, U1023, U1030, U1103, U1106,
U1107, U1108, U1109,
U1322, U1331, U1404, U1407, U1408,
U0218, U0309.
3) Tri Tann Pediatric Suspension
:
T1116, T1120, T1127, U1421.
4) Duotan Suspension 4 fl oz:
AE028, AD010, U1007, U1017, U1030,
U1126, U1217,
U1314, U1425, U1504;
Duotan Suspension 16 Fl oz:
AD010, AE004, AE028, AF012, U1002,
U1007, U1017,
U1025, U1030, U1126, U1128, U1217,
U1314, U1316,
U1425, U1504, U1513.
RECALLING FIRM/MANUFACTURER
DSC Products, Inc. (dba DCS Laboratories),
Muskegon, MI, by telephone and letter
no later then August 20, 2002.
FDA initiated recall is complete.
REASON
Lack of assurance of stability.
VOLUME OF PRODUCT IN COMMERCE
Approx. 142,000 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Triamcinolone Acetonide Cream
USP, 0.1%, NET WT. 1 lb. (453.6g)
jar, NDC-0472-0301-16. Recall # D-034-3.
CODE
Lot# 110080.
RECALLING FIRM/MANUFACTURER
Alpharma USPD, Inc., Lincolnton,
NC, by letters on or about September
19, 2002. Firm initiated recall is
ongoing.
REASON
Super-Potent.
VOLUME OF PRODUCT IN COMMERCE
5724 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Isosorbide Mononitrate EXTENDED-RELEASE
Tablets, 30 mg, 100 and 500 count
bottles, PUREPAC, Rx Only. Recall
# D-035-3.
CODE
Lots Exp. 135E1 7/2003 136E1 7/2003 137E1 7/2003 138E1 7/2003 139E1 7/2003 140E1 7/2003 173F1 8/2003.RECALLING FIRM/MANUFACTURER
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced.
Recall # B-0049-3.
CODE
Units 53J75427, 53J75439, 53J75444,
53J75447, 53J75461, 53J75470.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake
and Potomac Region, Baltimore, MD,
by telephone on March 7, 2002 and
by letter dated March 13, 2002. Firm
initiated recall is complete.
REASON
Blood products, collected from
a donor who hematocrit was incorrectly
calculated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MD and Washington DC.
_____________________________
PRODUCT
Source Plasma, Recall # B-0057-3.
CODE
Unit numbers 0480788024, 0480793262,
and 0480802262.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. (formerly
Nabi), Tempe, AZ, by letters on September
10 and December 27, 2001. Firm initiated
recall is complete.
REASON
Blood products, collected from
an unsuitable donor due to previous
positive testing for syphilis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC and the United Kingdom.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced.
Recall # B-0058-3.
CODE
Unit number 29GV47981.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA,
by telephone on March 5, 2002 and
by letter dated March 6, 2002. Firm
initiated recall is complete.
REASON
Blood product, collected from
an unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_____________________________
PRODUCT
a) Red Blood Cells. Leukocytes
Reduced, Recall # B-0059-3;
b) Recovered Plasma. Recall # B-0060-3.
CODE
a) and b) Unit number 29GP69957.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,Mid-Atlantic
Region, Norfolk, VA, by letters on
April 11 and April 16, 2002.
Firm initiated recall is complete.
REASON
Blood products, that tested negative
for viral markers, but were collected
from an ineligible donor due to a
risk factor for increased incidence
of infection with human immunodeficiency
virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and CA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0061-3;
b) Recovered Plasma, Recall # B-0062-3.
CODE
a) and b) Unit number 29KF15448.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA,
by letters on April 15 and April
22, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from
an ineligible donor due to medication
with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and CA.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0063-3.
CODE
Unit number FS02399.
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego,
CA, by telephone on July 15, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from
a donor whose body temperature was
not determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0064-3.
CODE
Unit number KW41496.
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego,
CA, by telephone on July 5, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from
an unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0050-3;
b) Red Blood Cells, Autologous, Recall
# B-0051-3;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated,
Recall # B-0052-3;
d) Platelets, Leukocytes Reduced,
Recall # B-0053-3
e) Fresh Frozen Plasma, Recall #
B-0054-3;
f) Recovered Plasma, Leukocytes Reduced,
Recall # B-0055-3.
CODE
a) Units J05850, J05852, J05853,
J05854, J05855, J05856,
J05859, J05860, J05861, R43824, R43826,
R43827, R43828, R43829, R43830, R43833,
R43835, R43836, R43838, R43839, R43840,
R43841, R43842, R43843, R43844;
b) Unit R43831;
c) Unit R43834;
d) Unit J05850, J05852, J05853, J05854,
J05855, J05856,
J05859, J05860, R43824, R43826, R43827,
R43828, R43829,
R43830, R43832, R43833, R43835, R43836,
R43838, R43839,
R43840, R43841, R43842, R43843, R43844;
e) Units J05859, R43836, R43843,
R43833, R43830;
f) Units J05850, J05852, J05853,
J05854, J05855, J05856,
J05860, J05861, R43824, R43826, R43827,
R43828, R43829,
R43832, R43834, R43835, R43838, R43839,
R43840, R43841,
R43842, R43844.
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus
Christi, TX, by fax dated March 28,
2002. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly
tested for the HIV-1 p24 antigen,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 25 units;
b) 1 unit;
c) 1 unit;
d) 25 units;
e) 5 units;
f) 22 units.
DISTRIBUTION
TX and CA.
****CORRECTION****
On the Enforcement Report 02-40 for October 9, 2002, Recall # Z-1451-1, Architect CA 19-9 Reagent Kit was list incorrectly. It should be Z-1451-2.
_____________________________
PRODUCT
Pulmonetic Systems Ventilators:
Models:
a) LTV-1000,Recall # Z-0010-3;
b) LTV-950, Recall # Z-0011-3;
c) LTV-900, Recall # Z-0012-3;
d) LTV-800. Recall # Z-0013-3.
CODE
a) Serial Numbers: A01030, A01038,
A01046, A01056,
A01057, A01063, A01085, A01088, A01114,
A01148, A01156,
A01157, A01161, A01181, A01210, A01213,
A01217, A01230,
A01258, A01270, A01302, A01307, A01311,
A01313, A01323,
A01331, A01337, A01343, A01393, A01414,
A01417, A01429,
A01431, A01434, A01436, A01453, A01456,
A01458, A01459,
A01492, A01496, A01498, A01499, A01536,
A01561, A01564,
A01574, A01582, A01588, A01633, A01637,
A01652, A01668,
A01671, A01677, A01682, A01737, A01747,
A01778, A01785,
A01794, A01815, A01816, A01846, A01847,
A01848, A01872,
A01876, A01880, A01893, A01906, A01912,
A01926, A01929,
A01937, A01938, A01974, A01980, A02016,
A02037, A02053,
A02068, A02078, A02127, A02128, A02137,
A02141, A02144,
A02149, A02159, A02181, A02197, A02219,
A02253, A02269,
A02290, A02359, A02374, A02416, A02422,
A02453, A02485,
A02490, A02550, A02553, A02647, A02669,
A02676, A02767,
A02774, A02779, A02784, A02795, A02797,
A02817, A02829,
A02834, A02857, A02871, A02884, A02887,
A02933, A02941,
A02947, A02987, A02988, A03013, A03069,
A03127, A03132,
A03138, A03141, A03143, A03146, A03230,
A03240, A03242,
A03248, A03267, A03290, A03291, A03307,
A03325, A03331,
A03336, A03341, A03346, A03356, A03361,
A03366, A03378,
A03379, A03381, A03383, A03391, A03402,
A03412, A03434,
A03440, A03454, A03456, A03459, A03464,
A03465, A03466,
A03471, A03482, A03500, A03540, A03541,
A03550, A03554,
A03574, A03607, A03608, A03614, A03619,
A03621, A03625,
A03638, A03652, A03658, A03661, A03672,
A03678, A03685,
A03686, A03693, A03694, A03711, A03713,
A03715, A03719,
A03720, A03724, A03733, A03735, A03743,
A03744, A03746,
A03762, A03804, A03814, A03853, A04053,
A04091, A04211,
A04212, A04213, A04215, A04216, A04217,
A04218, A04219,
A04220, A04222, A04223 - A04228,
A04230 - A04232,
A04235, A04237, A04238, A04239, A04243,
A04255, A04261,
A04262, A04263, A04269, A04453, A04471
— A04499,
A04501 — A04509, A04511 - A04650,
A04652, A04654,
A04655, A04657 - A04662, A04664,
A04665, A04668, A04670,
A04671, A04672, A04675 - A04684,
A04686, A04688 - 04694,
A04696 - A04718, A04720 - A04731,
A04733 - A04736,
A04738, A04739 - A04744, A04746,
A04748, A04749, A04753,
A04754, A04917 - and A04918 - A04941;
b) Serial Numbers: C01014, C01021,
C01031,
C01035, C01038, C01042, C01048, C01051,
C01052, C01056,
C01061, C01085, C01094, C01120, C01131,
C01134, C01140,
C01143, C01146, C01148, C01156, C01161,
C01164, C01165,
C01167, C01208, C01223, C01225, C01230,
C01231, C01247,
C01252, C01268, C01275, C01279, C01283,
C01288, C01293,
C01299, C01312, C01315, C01331, C01332,
C01365, C01370,
C01374, C01378, C01408, C01411, C01414,
C01435, C01436,
C01453, C01466, C01480, C01512, C01528,
C01530, C01536,
C01545, C01553, C01556, C01561, C01571,
C01574, C01578,
C01599, C01603, C01614, C01616, C01619,
C01622, C01632,
C01636, C01637, C01652, C01663, C01672,
C01677, C01681,
C01704, C01710, C01717, C01721, C01731,
C01732, C01770,
C01771, C01774, C01788, C01793, C01842,
C01854, C01862,
C01873, C01886, C01887, C01893, C01920,
C01929, C01930,
C01945, C01949, C01967, C01969, C01970,
C01974, C01992,
C01993, C01997, C02012, C02027, C02030,
C02075, C02079,
C02093, C02097, C02100, C02106, C02113,
C02134, C02141,
C02154, C02158, C02160, C02175, C02180,
C02181, C02185,
C02194, C02207, C02210, C02242, C02261,
C02277, C02278,
C02298, C02303, C02316, C02341, C02344,
C02346, C02402,
C02403, C02430, C02439, C02446, C02458,
C02465, C02522,
C02523, C02525, C02526, C02530, C02542,
C02550, C02551,
C02572, C02576, C02602, C02610, C02690,
C02694, C02708,
C02721, C02729, C02747, C02754, C02757,
C02763, C02777,
C02778, C02787, C02788, C02794, C02796,
C02797, C02805,
C02811, C02817, C02821, C02830, C02839,
C02844, C02849,
C02853, C02867, C02893, C02895, C02898,
C02899, C02908,
C02914, C02943, C02945, C02953, C02957,
C02971, C02977,
C03000, C03006, C03010, C03015, C03022,
C03033, C03071,
C03072, C03085, C03094, C03112, C03126,
C03131, C03145,
C03161, C03166, C03191, C03197, C03208,
C03221, C03263,
C03342, C03361, C03394, C03398, C03419,
C03464, C03482,
C03541, C03616, C03704, C03801 -
C03805, C03857, C03871,
C04080, C04093, C04179, C04259 -
04284, C04286 - C04301,
C04303 - C04308, C04334 - C04383,
C04410 - C04415,
C04417 - C04451, C04453 — C04463,
C04465, C04466,
C04468 - C04487, C04489, C04490 -
C04502,
C04504 - C04514, C04516 - C04538,
C04540 - C04584,
C04586 - C04588, C04590 - C04593,
C04595 - C04598,
C04603 - C04605, C04607 - C04634,
C04661 - C04663,
C04666, C04668, C04670, C04673 -
C04679, C04686,
C04687, C04688, C04689, C04690 -
C04711,
C04713 - C04729, C04731 - C04786,
C04788 - C04800,
C05052 - C05076, C05102 - C05113,
C05115,
C05119 - C05122, and C05124 - C05126;
c) Serial Numbers: B01002, B01003,
B01007, B01022, B01027,
B01033, B01056, B01066, B01070, B01086,
B01121, B01139,
B01146, B01162, B01181, B01196, B01210,
B01233, B01240,
B01256, B01261, B01265, B01266, B01271,
B01274, B01282,
B01289, B01326, B01331, B01345, B01375,
B01387, B01416,
B01421, B01435, B01444, B01472, B01475,
B01490, B01495,
B01514, B01523, B01550, B01558, B01560,
B01564, B01567,
B01576, B01583, B01589, B01590, B01598,
B01604, B01639,
B01645, B01658, B01663, B01669, B01675,
B01683, B01684,
B01685, B01709, B01749, B01750, B01760,
B01774, B01905,
B01914, B01915, B01934, B01943, B01968,
B02001, B02004,
B02033, B02035, B02061, B02064, B02108,
B02131, B02136,
B02143, B02144, B02145, B02149, B02152,
B02154, B02157,
B02158, B02162, B02163, B02171, B02182,
B02186, B02190,
B02404, B02428 - B02435, B02437 -
B02440,
B02442 - B02470, B02472 - B02496,
and B02498;
d) Serial Numbers: D01006, D01012,
D01093 - D01102, and
D01118 - D01127.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pulmonetic Systems,
Inc., Minneapolis, MN, by letter
dated September 30, 2002.
Manufacturer: Pulmonetic Systems,
Inc., Colton, CA.
Firm initiated recall is ongoing.
REASON
Printed circuit board malfunction
may result in the ventilator becoming
non-functional (no ventilation provided),
with a possibility of no audible
alarm sounding to alert the caregiver
to the situation.
VOLUME OF PRODUCT IN COMMERCE
1425 Ventilators.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Medtronic Midas Rex Legend Attachments.
Recall # Z-0037-3.
CODE
Serial Numbers: T0205, T0206,
T0267-T0273, T0284, T0285,
T0288, T0355-T0360, T0362, T0382,
T0383, T0385, T0386,
T0388, T0445, T0446, T0467-T0469,
T0471, T0472, T0525,
T0527, T0529-T0531, T0558, T0559,
T0561, T0564, T0566,
T0593, T0595, T0624, T0625, T0629,
T0632, T0633, T0636,
T0637, T0649, T0652, T0731, T0732.
RECALLING FIRM/MANUFACTURER
MIDAS REX, L.P. FORT WORTH, TX,
by telephone, letter and sales rep
follow up from August 9, 2002 through
August 16, 2002. Firm initiated recall
is complete.
REASON
The o ring can fall out or migrate,
causing difficulty of the attachment
engaging the motor.
VOLUME OF PRODUCT IN COMMERCE
309.
DISTRIBUTION
PA, FL, MI, VA, AZ, IL, OH and
CT.
_____________________________
PRODUCT
AxSYM Troponin-I Reagent Pack
list:
a) 3C29-20 (100 test pack);
b) 3C29-15 (50 test pack). Recall
# Z-0039-3.
CODE
a) lots 90172M300, 90172M301,
91268M300,
91268M301, 91269M300, 91269M301,
91270M300, 91270M301;
b) lots 91540M100, 91540M101, 91540M102,
87602M200.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Abbott
Park, IL, by letter dated September
26, 2002. Firm initiated recall is
ongoing.
REASON
Falsely high results.
VOLUME OF PRODUCT IN COMMERCE
a) 15,589 - 100 test kits;
b) 8,795 - 50 test kits.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
MicroFrance Instruments brand
of Monopolar, non-Laparoscopic Electrosurgical
(ESU) Instruments, Intended to remove
tissue and control bleeding. Recall
# Z-0040-3/Z-0096-3.
CODE
All serial numbers are involved
of the following Catalog/Model Numbers
(same):
CEP215, CP390-1 THROUGH CP390-11,
CP604M, CP605M, MCEN-100-2-0, MCEN100-2-5,
MCEN100-3-0, MCEN-100-3-5, MCEN100-4-0,
MCEN101, MCEN102, MCEN105, MCEN11,
MCO360-MCO363, MCO989, MCO990, MCO992,
MCO994, MCL20, MCL205, MCL21, MCL210,
MCL219, MCL219-1, MCL22, MCL23, MCL24,
MCL241, MCL241-1, MCL41, MCL41-1,
MCL59, MCL62, PS1CP390-7, PS1MCEN103,
PS1MCEN11, PS1MCL20, PS1MC0771F,
PS5, PS8, PS1CP390-3, PS1CP390-5,
PS1MCEN101 AND SMCEN100-3-0.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Xomed, Inc.,
Jacksonville, FL, by fax or letter
on August 28, 2002.
Manufacturer: Medtronic Xomed France
Sas Bourbon l'archambault. Firm initiated
recall is ongoing.
REASON
Dielectric withstand voltages
tested below acceptable limits.
VOLUME OF PRODUCT IN COMMERCE
1912.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Baxter Syntra 120 & 160 Single
Use Dialyzers; 24 dialyzers per case;
a) catalog R5M6243: Syntra*120 -
1.2 square meters surface
area. Recall # Z-0097-3;
b) catalog R5M6246: Syntra*160 -
1.6 square meters surface
area. Recall # Z-0098-3.
CODE
a) product code R5M6243, Model
120:
lot numbers: H01C05093, H01C26032,
H01D05034, H01D09036, H01D10091,
H01D30040, H01E02129, H01G02067,
H01G30068, H01H01075, H01H02032,
H01H24077, H01H25025, H01I23481,
H01I27029, H01I29017A, H01J13044,
H01J15155, H01L12505, H01L14048,
H02A29138, H02A30102, H02B02018,
H02C13112, H02C13112A, H02C15083,
H02C18152, H02C20133, H02C20133A,
H02F11044, H02F13065, H02F14196,
H02F14204, H02F17041, H02F18106,
H02F18494;
b) product code R5M6246, Model 160:
lot numbers:
H01D02023, H01D03096, H01D16023,
H01D17047, H01D18045,
H01D23045, H01D24498, H01D25495,
H01E03507, H01F18081,
H01F24493, H01F26068, H01H16057,
H01H19010, H01H26486,
H01I30031A, H01J02153, H01J11097,
H01K13034, H01K17035,
H01K18025, H01K21508, H01L03116,
H01L05178, H01L07026,
H01L09014, H01L10103, H02B03016,
H02B08049, H02B09047,
H02B10490, H02C01083, H02C03493,
H02C03493A, H02C07064,
H02C10506, H02C11561, H02D02071,
H02D07492, H02D22152,
H02D26112, H02F21118, H02F22025,
H02F25028, H02F29020.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare
Corp., Round Lake, IL, by letters
dated September 9, 2002.
Manufacturer: Baxter Healthcare Corporation,
Mountain Home, AR. Firm initiated
recall is ongoing.
REASON
Saline and blood leaks from the
header.
VOLUME OF PRODUCT IN COMMERCE
119,964.
DISTRIBUTION
CA, IN and Internationally.
_____________________________
PRODUCT
Novoste B-Rail 3.5F Delivery
Catheters. Recall # Z-0099-3
CODE
Catalog numbers: ABR-0340, ABR-6000
and CBR-6001.
RECALLING FIRM/MANUFACTURER
Novoste Corp., Norcross, GA,
by letters on or about August 19,
2002. Firm initiated recall is complete.
REASON
Catheter tip damage and detachment.
VOLUME OF PRODUCT IN COMMERCE
7345 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
CADD-Prizm High Volume Administration
Set, Reorder No. 21-7057-01, (for
use with the CADD-Prizm Pump). Recall
# Z-0100-3.
CODE
Lot No. 018X22
RECALLING FIRM/MANUFACTURER
Recalling Firm: Deltec, Inc.,
St. Paul, MN, by fax on July 31,
2002.
Manufacturer: Respiratory Support
Products, Inc., San Diego, CA. Firm
initiated recall is ongoing.
REASON
Some shelf cartons of High Volume
Administration Sets, Reorder 21-7057-01,
were incorrectly
labeled as High Volume Administration
Sets with 0.2 micron filter and injection
site, product 21-7055-01.
VOLUME OF PRODUCT IN COMMERCE
174 shelf cartons (each carton
containing 15 individual pouches
of product).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Livewire TC Bi-Directional Steerable
Electrophysiology Catheter, Large
Sweep, Reorder Number 402272. Recall
# Z-0102-3.
CODE
Lot numbers 02AF28, 02AF51, 02AF56,
and 02AG48.
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Daig Division,
Inc., Minnetonka, MN, by visit beginning
February 25, 2002. Firm initiated
recall is complete.
REASON
The push-pull wire of the device
can sometimes improperly protrude
through the catheter side-wall.
VOLUME OF PRODUCT IN COMMERCE
54 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Duet II Glucose Control Monitoring
System, In Charge tm.
Recall # Z-0103-3;
b) Duet Glucose Control Monitoring
System, Duet and ProPak
tm. Recall # Z-0104-3.
All Non-expired lots.
CODE
All Codes and Products.
RECALLING FIRM/MANUFACTURER
Lxn Corp., San Diego, CA., by
letter on August 16 or 19, 2002.
Firm initiated recall is ongoing.
REASON
Stability.
VOLUME OF PRODUCT IN COMMERCE
1,894,480.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
The contact lens is covered with
a sealed plastic envelope labeled
in part: "ACUVUE 2 (etafilcon A)
CONTACT LENS STERILE**BC**DIA**D**"
ALSO THE EXPIRATION DATE AND LOT
NUMBER IS ON THE LENS (MASTER AND
TRAIL).The lens shelf box is labeled
in Part: "***ACUVUE 2 BRAND CONTACT
LENSES Johnson & Johnson VISTAKON,
Jacksonville, Florida**Contents 6
lenses (58% H20) in buffered saline**
LOT**PRODUCT CODE ***" Recall # Z-0110-3.
CODE
The following lot numbers are
under recall and they represent a
standard "Master" lot number and
a unique out of sequence "trail"
code too numerous to list (over 3500
different out of sequence digits).
ONLY THE ENTIRE CODE INCLUDING THE
TRAIL CODE IS UNDER RECALL. THERE
ARE LENSES NOT UNDER RECALL THAT
HAVE THE SAME FIRST 6 MASTER CODE
DIGITS BUT DIFFERENT TRAIL CODES.
The firm can be called by the consignee/patient
with the lot number to see if its
under recall although all direct
accounts will have their unique codes
that are under recall listed on their
recall letter. The Master codes are
(the "XXX" in parentheses represents
the unique trail code):
Lot B000GRS (XXX) (-3.00 D, 8.7 B.C.);
Lot B000WTK (XXX) (-2.50 D, 8.3 B.C.);
Lot B000WJK (XXX) (-5.00 D, 8.7 B.C.);
Lot B000JKV (XXX) (+4.50 D, 8.7 B.C.);
Lot B000JKW (XXX) (+4.50 D, 8.7 B.C.);
Lot B000JHJ (XXX) (-8.00 D, 8.3 B.C.);
Lot B000JHK (XXX) (-7.00 D, 8.3 B.C.).
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Vision
Products, Inc., Jacksonville, FL,
by telephone on September 27, 2002.
Firm initiated recall is ongoing.
REASON
Firm cannot adequately document
if product lot went through sterilization.
VOLUME OF PRODUCT IN COMMERCE
3476.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
BD Interlink Lever Lock Cannula,
reorder number 303370.
Blunt plastic cannula, Used for Aspiration/Injection
of fluids. Recall # Z-0112-3.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson
& Co., Franklin lakes, NJ, by
letter on February 25, 2002.
Manufacturer: Becton Dickinson &
Co., Columbus, NE.
Firm initiated recall is complete.
REASON
Leakage.
VOLUME OF PRODUCT IN COMMERCE
63,479,000 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Siemens Fluorospot compact, Digital
image storage and processing. Recall
# Z-0113-3.
CODE
Siemens Part # 3078560, 3111668,
3111676, 5902767, 5902775
Serial Numbers: 01516, 01517, 01527,
01528, 01529,, 01530,
24017, 24018, 24020, 24021, 24023,
24025, 24026, 24027,
24028, 34076, 34089, 34091, 34094,
34095, 34096, 34098, 34100, 34105,
34106, 34107, 34108, 34110, 34111,
34112, 34114, 34115, 34116, 34118,
34120, 34121, 34122, 34123, 34124,
34126, 34127, 34128, 34129, 34130,
34133, 34134, 34135, 34136, 01007,
01008, 01219, 01228, 01413, 01444,
01452, 01477, 01484, 01021, 01205,
01211, 01213, 01215, 01234, 01403,
01406, 01411, 01413, 01417, 01418,
01421, 01422, 01423, 01424, 01428,
01443, 01454, 01456, 01457.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical
Systems, Inc., Iselin, NJ, by letter
on June 13, 2002.
Manufacturer: Siemens Medical Solutions
Erlangen, Germany.
Firm initiated recall is complete.
REASON
Incorrect labeling of images
in DICOM composed format.
VOLUME OF PRODUCT IN COMMERCE
78 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Stryker Adel Advanced Delivery
System Maternity Bed,
Model 4700;
b) Stryker Adel Advanced Delivery
System Maternity Bed,
Model 5012;
Recall # Z-0114-3.
CODE
All units distributed from September
2001 and July 2002.
RECALLING FIRM/MANUFACTURER
Stryker Corp., Kalamazoo, MI,
by letter on September 19, 2002.
Firm initiated recall is ongoing.
REASON
Foot section may fall off when
the bed is moved.
VOLUME OF PRODUCT IN COMMERCE
421 beds.
DISTRIBUTION
Nationwide and Australia, Canada,
Chile, Hong Kong, Netherlands, Spain,
Switzerland, Taiwan.
_____________________________
PRODUCT
Aesculap Ti Bone Screws, 4x56
mm. Recall # Z-0116-3.
CODE
Lot number 5634922.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap, Inc.,
Center Valley, PA, by letters on
June 14, 2002.
Manufacturer: Aesculap Ag & Co.
Kg. Tuttlingen, Donau.
Firm initiated recall is complete.
REASON
Smaller than specified core diameter
may lead to screw breakage during
and post-implantation.
VOLUME OF PRODUCT IN COMMERCE
55 units.
DISTRIBUTION
FL, NJ, and UT.
_____________________________
PRODUCT
Bayer Glucometer Esprit 2 Blood
Glucose Meter; product code 3960.
Recall # Z-0117-3.
CODE
Product code 3960; all units
sold in South Africa.
RECALLING FIRM/MANUFACTURER
Bayer Corp., Elkhart, IN, by
visit in September 2002.
Firm initiated recall is complete.
REASON
Inappropriate measurement system
for South African market.
VOLUME OF PRODUCT IN COMMERCE
300.
DISTRIBUTION
South Africa.
_____________________________
PRODUCT
Amana Model LD10 and LD10D Commercial
Microwave Oven. Recall # Z-1227-2.
CODE
Serial numbers beginning 0104.
(The serial tag can be located by
opening the oven door and looking
on the left side of the control panel.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maytag Appliances,
Amana Commercial Products Amana,
IA, by letters dated May 17, 2002.
Manufacturer: LG Electronics Inc.
Gyeong, Nam, Korea.
Firm initiated recall is complete.
REASON
Microwave emission exceeded the
power density limit.
VOLUME OF PRODUCT IN COMMERCE
1,192 ovens.
DISTRIBUTION
Nationwide, Canada and Mexico.
_____________________________
PRODUCT
Portex Spinal Tray 25G Whitacre
Needle. Recall # Z-0038-3.
CODE
Catalog Number: 49651-25;
Lot Number: K131988;
Exp. Date 01/2004.
RECALLING FIRM/MANUFACTURER
Portex, Inc., Keene, NH, by letter
on September 25, 2002.
Firm initiated recall is ongoing.
REASON
Spinal tray incorrectly packaged
with a Quincke spinal needle instead
of a Whitacre spinal needle.
VOLUME OF PRODUCT IN COMMERCE
1160 trays.
DISTRIBUTION
FL, MI, MO, NY, OR, PA, RI and
WA.
_____________________________
PRODUCT
Acuson brand Aspen® Diagnostic
Ultrasound System
Catalog Numbers: 82-47888, 82-61531,
82-47887, 82-53683. Recall # Z-0105-3/Z-0108-3.
CODE
Serial number beginning with
"3" followed by other digits (e.g.,
3XXXX).
RECALLING FIRM/MANUFACTURER
Acuson Corp., Mountain View,
CA, by letters dated August 6, 2002.
Firm initiated recall is ongoing.
REASON
Product labeling did not include
ALARA (As Low As Reasonably Achievable)
safety instructions.
VOLUME OF PRODUCT IN COMMERCE
600 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Somatom Sensation 16 systems.
Software upgrade from Somaris/5 VA50A
to VA50B.
Recall # Z-0109-3.
CODE
Model Number 7393114.
Four serial numbers 50012, 50022,
50025, 50029.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical
Systems, Inc., Iselin, NJ, by letter
in July 2002.
Manufacturer: Siemens Medical Solutions,
Erlangen, Germany.
Firm initiated recall is ongoing.
REASON
Scans may be aborted if scans
are started manually.
VOLUME OF PRODUCT IN COMMERCE
4.
DISTRIBUTION
OH, NC and MA.
_____________________________
PRODUCT
Disposable Sensory Needle Electrodes,
Model Numbers:
a) 9013R0222 (0.70mm X 30mm);
b) 9013R0252 (0.35mm X 30mm);
c) 9013R0271 (0.35mm X 20mm).
Recall # Z-0111-3.
CODE
a) Lot 2663049;
b) Lot 2617881;
c) Lot 2601944.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Gastroenterology
& Urology Shoreview, MN, by letter
dated September 13, 2002.
Manufacturer: Medtronic A/S 2740
Skovlunde.
Firm initiated recall is ongoing.
REASON
Some needles were not the length
specified on labeling.
VOLUME OF PRODUCT IN COMMERCE
1200 Disposable Sensory Needle
Electrodes.
DISTRIBUTION
CA, MA and Europe, Brazil and
Hong Kong.
END OF ENFORCEMENT REPORT FOR OCTOBER 23, 2002
####
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