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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August 3, 2005
05-31

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS

______________________________
PRODUCT
Nabisco 100 Calorie Packs Oreo Thin Crisps Baked Chocolate Wafer Snacks, 4.86 oz. cartons containing six individual serving bags, 6 cartons per case, UPC 446170, Recall # F-544-5
CODE
Best When Used By 04DEC05BD case code 5338BD
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Inc., Northfield, IL, by press release on July 11, 2005.
Manufacturer: Consolidated Biscuit Company, Mc Comb, OH. Firm initiated recall is ongoing.
REASON
Some of the boxes of Nabisco 100 Calorie Packs Oreo Thin Crisps may contain some individual bags of Nabisco 100 Calorie Packs Chips Ahoy Thin Crisps which are made with milk, not declared on the Oreo box.
VOLUME OF PRODUCT IN COMMERCE
17,102 cases
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Beef and Cheese sub sandwich, net wt. 8 oz.,
EASTSIDE DELI brand, Recall # F-547-5;
b) Beef and Cheese sandwich on wheat bread,
net wt. 6 oz., FRESH FROM THE DELI brand,
Recall # F-548-5;
c) Ham and cheese submarine sandwich, net wt.
8 oz., EASTSIDE DELI brand, Recall # F-549-5;
d) Ham and swiss on onion sub bun, net wt. 8 oz.,
EASTSIDE DELI brand, Recall # F-550-5;
e) Ham and cheese sandwich on wheat bread,
net wt. 5.5 oz., EASTSIDE DELI brand,
Recall # F-551-5;
f) Ham and cheese sandwich on white bread,
net wt. 6 oz. or 229 grams, FRESH FROM
THE DELI brand, Recall # F-552-5;
g) Ham and cheese sandwich on white sub bun,
net wt. 4 oz., In Your Belly Deli brand,
Recall # F-553-5;
h) Ham and cheese buddy sandwich on white bun,
net wt. 6.5 and 8 oz., EASTSIDE DELI brand,
and Fresh from the Deli brand,
Recall # F-554-5;
i) Charbroil beef patty sandwich on white bun,
net wt. 4.75 oz., In Your Belly Deli brand,
Recall # F-555-5;
j) Super beef patty sandwich on white seeded bun,
net wt. 5.5 oz., EASTSIDE DELI brand,
In Your Belly Deli and FRESH FROM THE DELI
brand labels. Recall # F-556-5;
k) Super beef patty on white bun sandwich, net
wt. 7 oz., FRESH FROM THE DELI brand,
Recall # F-557-5;
l) Gigantic cheeseburger on white seeded bun,
100% ground beef, net wt. 6.5 oz., EASTSIDE
DELI brand, Recall # F-558-5;
m) Gigantic beef burger on white seeded bun,
100% pure beef, net wt. 7.5 oz., Fresh from
the Deli brand, Recall # F-559-5;
n) 'MEGA' Bacon cheeseburger sandwich on white
seeded bun, net wt. 8.5 oz., EASTSIDE DELI
brand, Recall # F-560-5;
o) Bacon & Beef Patty sandwich on white seeded
bun, Net wt. 7 oz., FRESH FROM THE DELI brand,
Recall # F-561-5;
p) Char-Broiled Pork Rib sandwich on sesame seed
bun, net wt. 4.5 oz., In Your Belly Deli brand,
Recall # F-562-5;
q) Turkey and cheese sandwich, net wt. 8 oz.,
EASTSIDE DELI brand, Recall # F-563-5;
r) Turkey and cheese sandwich, net wt. 8 oz.,
EASTSIDE DELI brand, Recall # F-564-5;
s) Turkey and cheese Buddy sandwich on white bun,
Net wt. 6.5 oz., EASTSIDE DELI brand,
Recall # F-565-5;
t) Turkey and cheese sandwich on wheat bread,
Net wt. 6.5 oz., FRESH FROM THE DELI brand,
Recall # F-566-5;
u) Ham & Turkey Hoagie sandwich on hoagie bun,
Net wt. 5.5 oz., EASTSIDE DELI brand,
Recall # F-567-5;
v) Ham & Turkey Hoagie sandwich on sesame seeded
bun, Net wt. 5.5 oz., FRESH FROM THE DELI
brand, Recall # F-568-5;
w) Twin chili cheese dogs on hot dog buns,
Net wt. 6.5 and 7.8 oz., EASTSIDE DELI
brand, and FRESH FROM THE DELI brand,
Recall # F-569-5;
x) Tuna salad sandwich on wheat bread, Net wt.
5.5 oz., EASTSIDE DELI brand, and FRESH
FROM THE DELI brand, Recall # F-570-5;
y) Giant Eastsider sandwich on original flat bread,
net wt. 6.5 oz., FRESH FROM THE DELI brand,
Recall # F-571-5;
z) Cold cut combo Hoagie sandwich on white bread,
net wt. 6.5 oz., FRESH FROM THE DELI brand,
Recall # F-572-5;
aa) Egg Salad sandwich on wheat bread, net wt.
5 oz. and 5.5 oz, EASTSIDE DELI brand, and
FRESH FROM THE DELI brand, Recall # F-573-5;
bb) Chicken sandwich on plain white bun, net wt.
5.5 oz., In Your Belly Deli brand,
Recall # F-574-5;
cc) Chicken salad sandwich, Net wt. 5 oz. and
5.5 oz., EASTSIDE DELI brand, and FRESH FROM
THE DELI brand, Recall # F-575-5;
dd) Chicken & swiss sandwich on plain bun, net wt.
5.5 oz., FRESH FROM THE DELI brand,
Recall # F-576-5;
ee) Southern fried chicken sandwich on plain bun,
net wt. 5.5 oz., EASTSIDE DELIbrand, and FRESH
FROM THE DELI brand, Recall # F-577-5;
ff) Spicy chicken & swiss sandwich on multi
grain bun, net wt. 5.5 oz., FRESH FROM THE
DELI brand, Recall # F-578-5;
gg) Spicy chicken w/swiss Buffalo style sandwich
on multi grain bun, net wt. 5.5 oz., EASTSIDE DELI
brand, Recall # F-579-5
CODE
All sandwiches dated April 4, 2005 or earlier.
RECALLING FIRM/MANUFACTURER
Eastside Deli Supply Inc, by press release on March 8, 2005 and March 18, 2005. Firm initiated recall is complete.
REASON
The products may be contaminated with Listeria monocytogenes based on the State of Michiganís analysis.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
IN, MI, and OH

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

______________________________
PRODUCT
Golden Flower brand Dried Ginger, Net Wt. 6 oz. 170 g). Product of China. Barcode # 6 47406 011850, Recall # F-545-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prosperity Resources International, Irvington, NJ, by letters, dated May 24, 2005, and June 3, 2005.
Manufacturer: S & Y Co., Ltd., Guangdong, China. Firm initiated recall is ongoing.
REASON
The product contains Ponceau 4R, an unapproved color additive. The product also contains undeclared color sunset yellow FCF (certifiable as FD&C Yellow #6) and undeclared sulfites (38 ppm). These findings are based on sampling & analysis by the New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
30 cases (50/6 oz. packages per case)
DISTRIBUTION
MA, OH, IL, and NY
______________________________
PRODUCT
Basa Fish Fillets: a) Basa, IQF frozen farm raised fish fillets, 3-5 ounces 15 pound bulk package,
b) Basa, IQF frozen farm raised fish fillets, 7-9 oz fillets, 15 pound bulk package, Recall # F-546-5
CODE
a) Production date 30/01/2007 on the 3-5 oz. fillets;
b) Production date 18/11/2004 on the 7-9 oz. fillets
RECALLING FIRM/MANUFACTURER
John Seafood (835 Sp), Westwego, LA, by fax on May 12, 2005. Firm initiated recall is ongoing.
REASON
Potential risk of adverse health events due to consuming fluoroquinolone antibiotic residues in catfish fillets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Maxipime (cefepime hydrochloride, USP) for Injection, Equivalent to 1 gram, 15mL Single-Dose Vial, box of 10 vials, For IV or IM Use after constitution, Rx only, NDC 51479-054-30, Recall # D-381-5
CODE
Lots: 5E02293, exp 4/30/2008; 5E01410, exp 4/30/2008; 5E00604, exp 4/30/2008; 5E01868, exp 3/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol Meyers Squibb Company, New Brunswick, NJ, by telephone on June 15, 2005, and by letter on June 24, 2005.
Manufacturer: Bristol-Myers Squibb S.r.l., Sermoneta-Latina, Italy. Firm initiated recall is ongoing.
REASON
Mislabeled; incorrect bar code on 10-pack tray. Bar code indicates 2 gram vials instead of 1 gram vials.
VOLUME OF PRODUCT IN COMMERCE
266,940
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Hyoscyamine Sulfate Oral Solution, USP, Hyoscyamine Sulfate, USP 0.125mg, Alcohol 5%, 15mL bottle, Rx only, NDC 0603-1314-73, Recall # D-433-5
CODE
Lot L030L04A, Exp 11/06
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letters on June 20, 2005. Firm initiated recall is ongoing.
REASON
Impurity; extraneous peak was discovered during routine long-term stability testing.
VOLUME OF PRODUCT IN COMMERCE
11,611 units
DISTRIBUTION
Nationwide and PR

_______________________________
PRODUCT
a) Stannous Flouride 0.63% Concentrate Oral Rinse,
10 oz (283 g) bottle, Mint Flavor, Rx only, 39110,
NDC 60258-159-10, Recall # D-434-5;
b) Andehist -NR Syrup, Each teaspoonful (5mL) contains:
4mg and Pseudoephedrine Hydrochloride 45mg, 16 fl oz
(473 mL) bottle, Rx only, NDC 60258-434-16,
Recall # D-435-5;
c) Andehist-NR Oral Drops, Each dropperful (1mL)
contains: Carbinoxamine Maleate 1mg and
Pseudoephedrine Hydrochloride 15mg, 1 fl oz
(30mL) bottle, Rx only, NDC 60258-435-30,
Recall # D-436-5;
d) Andehist-DM NR Syrup, Each teaspoonful (5mL)
contains: Brompheniramine Maleate 4mg,
Pseudoephedrine Hydrochloride 45mg and
Dextromethorphan Hydrobromide 15mg, 16 fl oz
(473 mL) bottle, Rx only, NDC 60258-444-16,
Recall # D-437-5;
e) Bromhist-DM Drops, Each dropperful (1mL)
contains: Brompheniramine Maleate 1mg,
Pseudoephedrine Hydrochloride 15mg and
Dextromethorphan Hydrobromide 4mg, 1 fl oz
(30mL) bottle, Rx only, NDC 60258-447-30,
Recall # D-438-5;
f) Dytan Suspension, Each 5mL (one teaspoonful)
contains: Diphenhydramine Tannate 25mg, 4 fl oz
(120mL) bottle, Rx only, NDC 63717-570-04,
Recall # D-439-5;
g) Dytan-D Suspension, Each 5 mL (one teaspoonful)
contains: Diphenhydramine Tannate 25mg and
Phenylephrine Tannate 7.5 mg, 4 fl oz (118mL),
Rx only. NDC 63717-576-04, Recall # D-440-5
CODE
a) Lot Nos.: L402003, 402004;
b) Lot Nos.: 3K06, L401002, 3L06, 3L05;
c) Lot Nos.: 3L07, 3L08;
d) Lot Nos.: 3L02, 3L03, L401001;
e) Lot No.: 3L06;
f) Lot Nos.: L409001A, L409002A;
g) Lot Nos.: L401007, L401008, L401009, L401010,
L4034002, L404002, L404003, L404004, L404005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Pharmaceutical, Inc, Madison, MS, by letter on May 27, 2005. Manufacturer: Able Laboratories, Inc., Cranbury, NJ. Firm initiated recall is ongoing.
REASON
Lack of assurance that testing conducted for release and stability conformed to standard operating procedures (Able Labs)
VOLUME OF PRODUCT IN COMMERCE
156,197 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
CVS pharmacy brand Wart Remover, Maximum Strength, Salicylic Acid, 17% w/w, Net Wt. ½ oz (14mL); Over the Counter, UPC # 0 50428 21032, Recall # D-382-5
CODE
Lot Nos. 5A012A (exp. 01/07) and 5E001 (exp. 02/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Clay Park Labs, Inc., Bronx, NY, by telephone on July 12, 2005, and by letters, dated July 13, 2005 and July 14, 2005.
Manufacturer: Pharma Pac LLC, De Kalb, MS. Firm initiated recall is ongoing.
REASON
Mislabeled: cartons of CVS pharmacy brand Wart Remover (Liquid) were printed with the Drug Facts Panel referencing Corn Remover (Liquid).
VOLUME OF PRODUCT IN COMMERCE
45,642 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Renaphro Softgels, Each softgel contains: Vitamin C 100mg, Folic Acid 1mg, Niacinamide 20mg, Thiamine Mononitrate 1.5mg, Riboflavin 1.7mg, Vitamin B6 10mg, Vitamin B12 6mcg, Calcium Pantothenate 5mg and Biotin 150 mcg, 100 count bottles, Stress/Dialysis Vitamin, Rx only, NDC 64980-114-01. Recall # D-441-5
CODE
All lots whose first 3-digits start with ì664î.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rising Pharmaceuticals, Inc., Allendale, NJ, by letter on July 7, 2005.
Manufacturer: Strides Inc., Somerset, NJ. Firm initiated recall is ongoing.
REASON
Subpotent; calcium pantothenate
VOLUME OF PRODUCT IN COMMERCE
208,692 Units (100's) were distributed
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-1579-5
CODE
Unit number: X30805
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility, of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1637-5
CODE
Unit number: 22GH13096
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on March 20, 2005, and by letter on March 21, 2005. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1718-5
CODE
Unit number: 71M14782-8
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Source Plasma, Recall # B-1720-5
CODE
Unit numbers: LC0404619, LC0405054, LC0405211, and LC0405515
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by facsimile on August 13, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of disqualifying information concerning previous incarceration of the donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1721-5;
b) Fresh Frozen Plasma, Recall # B-1722-5
CODE
a), and b) Unit number: 49N29157
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on May 25, 2004, and by letter on June 3, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible due to previous reactive testing for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and OK

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-1787-5
CODE
Unit number: 22KG38367
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Philadelphia, PA, by letter dated November 16, 2000. Firm initiated recall is complete.
REASON
Blood product, which was not prepared in accordance with acceptable specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1822-5;
b) Recovered Plasma, Recall # B-1823-5
CODE
a), and b) Unit number: 06GH40008
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by electronic mail on June 4, 2005 and by letters dated June 11, July 7, and 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reported to having close contact with an individual with hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1824-5
CODE
Unit number: 242176172
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on December 4, 2002. Firm initiated recall is complete.
REASON
Blood product, which may have been hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Source Plasma, Recall # B-1575-5
CODE
Unit number: 75849474
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Newport, KY, by fax on September 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Frozen Plasma, Recall # B-1584-5
CODE
Unit number: 29GK59650
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on December 17, 2004, and by letter dated December 22, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood donation that had discrepant start and stop times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Whole Blood, Recall # B-1587-5;
b) Red Blood Cells, Recall # B-1588-5;
c) Red Blood Cells, Leukoreduced,
Recall # B-1589-5;
d) Red Blood Cells, Irradiated, Recall # B-1590-5;
e) Fresh Frozen Plasma, Recall # B-1591-5;
f) Cryoprecipitated AHF, Recall # B-1592-5;
g) Platelets, Recall # B-1593-5;
h) Platelets, Irradiated, Recall # B-1594-5;
i) Platelets, Pheresis, Recall # B-1595-5;
j) Platelets Pheresis, Irradiated, Recall # B-1596-5;
k) Platelets, Pheresis, Leukoreduced,
Recall # B-1597-5;
l) Platelets, Pheresis, Leukoreduced, Irradiated,
Recall # B-1598-5;
m) Recovered Plasma, Recall # B-1599-5
CODE
a) Units: GW48835, KP 48942 GW47387 GW48993 GW49024 GW49035
GW49036 GW49044 GW49078;
b) Unit numbers: KH87957 KH87959 KH87961 KH87965 KH87966
KH87967 KH87968 KH87969 KH87970 KH87971 KH87972 KH87973
KH87974 KH87975 KH87979 KH87980 KH87981 KH87982 KH87983
KH87984 KH87985 KH87986 KH87987 KH87988 KH87989 KH87990
KH87991 KM44902 KM44903 KM44904 KM44906 KM44907 KM44908
KM44909 KM44910 KM44911 KM44913 KM44914 KR26762 KR26763
KR26764 KR26766 KR26767 KR26769 KR26770 KR26772 KR26773
KR26774 KR26775 KR26776 KR26777 KR26779 KR26781 KR26782
KR26783 KR26784 KR26785 KR26786 KR26787 KN51600 KN51601
KN51602 KN51603 KN51604 KR26789 KR26790 KR26791 KR26792
KR26793 KR26794 KR26795 KR26796 KR26797 KR26798 KR26800
KR26801 KR26803 KR26804 KR26805 KR26806 KR26810 KR26811
KR26812 KR26813 KR26817 KR26819 KF24852 KM44941 KM44942
KM44943 KM44944 KM44945 KM44946 KM44947 KM44948 KM44949
KM44950 KM44951 KM44953 KM44954 KM44956 KM44957 KM44958
KN51666 KN51667 KN51669 KN51670 KN51671 KN51672 KN51675
KN51676 KN51678 KN51679 KN51680 KN51681 KN51682 KN51684
KN51685 KN51686 KN51687 KN51688 KN51689 KN51690 KN51691
KN51695 KN51696 KN51697 KN51698 KN51699 KP49401 KQ40013
KQ40014 KQ40015 KQ40016 KQ40018 KQ40019 KQ40020 KQ40021
KQ40022 KQ40023 KQ40024 KQ40025 KQ40033 KQ40036 KF24874
KP48965 KH88130 KH88139 KH88141 KH88143 KH88144 KH88147
KH88148 KH88149 KM45000 KM45001 KM45004 KM45006 KN51747
KN51749 KN51750 KN51751 KN51752 KN51753 KN51754 KN51755
KN51756 KN51757 KN51758 KN51759 KN51761 KN51762 KN51766
KN51767 KN51768 KN51769 KQ40122 KQ40124 KQ40127 KQ40128
KQ40130 KQ40131 KE79691 KE79695 KE79696 KE79705 KE79708
KE79712 KE79713 KE79714 KE79715 KE79720 KQ40132 KQ40133
KQ40134 KQ40135 KQ40136 KQ40137 KQ40138 KE79752 KE79755
KE79757 KE79758 KE79759 KP49412 KN51787 KN51803 KR26841;
c) Unit numbers: KR26771 KR26778 KN51605 KR26788 KF24853
KM44955 KQ40029 KH88131 KN51746 KN51748 KQ40125 KQ40126
KE79694 KE79707 KE79718;
d) Unit numbers: KH87964 KH87978 KM44905 KR26761 KR26768
KN51597 KN51598 KR26809 KM44960 KM44966 KN51693 KQ40017
KQ40028 KQ40030 KQ40031 KH88133 KM45002 KM45003 KN51760
KE79706 KE79754;
e) Unit numbers: KN51606 KR26791 KM44964 KN51667 KN51683
KN51699 KM45006 KQ40124 KQ40130 KQ40137;
f) Unit number: KH88141;
g) Unit numbers: KH87968 KH87969 KH87970 KH87972 KH87975
KH87980 KM44904 KM44906 KM44907 KM44909 KR26772 KR26786
KM44944 KM44945 KM44946 KM44949 KM44953 KM44955 KM44964
KN51666 KN51667 KN51676 KN51678 KN51679 KN51682 KN51683
KN51684 KN51697 KN51698 KQ40015 KQ40016 KQ40020 KQ40029
KQ40030 KQ40031 KC59898 KH88136 KH88137 KH88139 KH88140
KH88143 KH88144 KH88149 KN51751 KN51752 KN51759 KN51762
KQ40122 KQ40124 KE79691 KE79695 KE79705 KE79712 KE79713
KE79714 KE79715 KE79720 KQ40132 KQ40133 KQ40136 KE79722
KE79756 KQ40762;
h) Unit numbers: KH87973 KH87974 KH87978 KH87982 KH87983
KH87984 KH87985 KH87986 KH87987 KH87988 KH87990 KH87991
KM44905 KM44908 KM44910 KM44913 KR26761 KR26762 KR26763
KR26764 KR26766 KR26767 KR26768 KR26769 KR26770 KR26771
KR26773 KR26774 KR26776 KR26777 KR26778 KR26779 KR26781
KR26782 KR26783 KR26785 KN51597 KN51602 KN51604 KN51605
KN51606 KR26788 KR26789 KR26790 KR26791 KR26792 KR26796
KR26797 KR26800 KR26801 KR26802 KR26804 KR26806 KR26807
KR26808 KR26809 KR26812 KR26814 KR26819 KM44941 KM44948
KM44950 KM44957 KM44958 KM44959 KM44963 KN51662 KN51664
KN51670 KN51675 KN51677 KN51681 KN51686 KN51688 KN51690
KN51696 KQ40017 KQ40018 KQ40033 KH88130 KH88131 KH88132
KH88133 KH88134 KH88135 KH88138 KH88141 KH88142 KH88145
KH88146 KH88147 KH88148 KM44999 KM45000 KM45001 KM45002
KM45003 KM45004 KM45006 KN51745 KN51746 KN51747 KN51753
KN51754 KN51756 KN51757 KN51760 KN51761 KN51763 KN51766
KN51767 KN51768 KN51769 KQ40121 KQ40123 KQ40125 KQ40126
KQ40127 KQ40128 KQ40130 KQ40131 KE79688 KE79689 KE79690
KE79706 KE79707 KE79711 KE79718 KE79719 KQ40138 KE79752
KE79755 KE79758 KE79779 KN51803;
i) Unit number: KZ52850;
j) Unit number: KZ52852;
k) Unit numbers: KZ52848 KZ52849 KZ52851 KZ52930 KZ52951;
l) Unit numbers: KZ52928, KZ52929, KZ52929;
m) Unit numbers: KH87957 KH87964 KH87977 KH87979 KH87982
KH87985 KH87986 KH87987 KH87988 KM44902 KM44903 KM44904
KM44905 KM44906 KM44907 KM44908 KM44909 KM44910 KM44911
KM44913 KM44914 KR26761 KR26762 KR26763 KR26764 KR26766
KR26767 KR26768 KR26769 KR26770 KR26771 KR26772 KR26773
KR26774 KR26775 KR26776 KR26777 KR26778 KR26779 KR26799
KR26806 KR26808 KR26809 KR26810 KR26811 KR26812 KR26813
KR26814 KR26816 KR26817 KR26819 KF24831 KN51633 KN51659
KR26827 KM44942 KM44943 KM44945 KM44946 KM44949 KM44950
KM44951 KM44954 KM44957 KM44959 KM44960 KM44965 KN51664
KN51678 KN51689 KQ40013 KQ40014 KQ40016 KQ40017 KQ40018
KQ40019 KQ40020 KE79595 KL84897 KQ40754 KN51768 KE79712
KE79713 KE79716 KE79718 KE79719
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by fax on or about July 30, 1998, and again on August 7, 1998. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for hepatitis core antibody (Anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
579 units
DISTRIBUTION
VA, DC, and Switzerland

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1636-5
CODE
Unit number: 22KL18252
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on March 18, 2005, and by letter on March 31, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1672-5;
b) Red Blood Cells, Leukoreduced, Irradiated,
Recall # B-1673-5;
CODE
a) Unit numbers: 35FC48314, 35FC57082, 35FC61723;
b) Unit number: 35FC44630
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Blood Services region, Roanoke, VA, by fax on December 30, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled as C-antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA and AK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1711-5
CODE
Unit numbers 41LX33091, 41GQ87237, 41GQ87222, 41LR65662, 41FT49800, 41FT49802, 41FT49804, 41FT48916, 41FT49819, 41FT49827, 41FV46382, 41FV46393, 41FV46405, 41LX33083, 41LX33086, 41LX33090, 41LX33096, 41FT49843, 41FX35566, 41LR65614, 41LR65686, 41LR65687, 41LR65688, and 41GQ87242
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Huntsville, AL, recall by telephone on August 17, 2000, and by letter on August 24, 2000. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
AL

_______________________________
PRODUCT
a) Whole Blood, Recall # B-1712-5;
b) Red Blood Cells, Recall # B-1713-5;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-5;
d) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1715-5;
e) Plasma, Cryoprecipitate Reduced, Recall # B-1716-5;
f) Fresh Frozen Plasma, Recall # B-1717-5
CODE
a) Unit number: 41GR17779;
b) Unit numbers: 41GR17750, 41LS61115, and 41LV18499;
c) Unit numbers: 41FR45745, 41LV18510, 41LV18500,
41LV18496, 41FY14332, 41LV18513, 41FQ74250, 41FQ74255,
41FQ74261, 41FQ74265, 41FQ74271, 41FQ74277, 41GJ62711,
41GN30149, 41GN30151, 41GQ86600, 41GR17760, 26FK45835,
26FK45838, 26FL15698, 26FM83973, 26FM84074, 26FX00191,
26FY08673, 26KE38383, 26KE38385, 26KG35655, 40GF33440,
40GF33444, 41GE52521, 26KJ16937, 26KJ16942, 26KJ16943,
26KM20115, 41FV46122, 41FV46355, 41GE52489, 41GE52502,
19GC11044, 19GF95803, 19GF95833, 19GJ68682, 19GJ68687,
19GJ68692, 19GJ68693, 19GN72527, 19GN72829, 19GN72839,
19GN72840, 19GN72841, 19GN72854, 19GN72879, 19GR33009,
19GR33015, 19GR33016, 19GR33020, 19GR33024, 19GR33028,
19GF96136, 19GR33031, 19GZ60192, 19LQ22953, 19LW07331,
41FL88054, 41FY14301, 41FY14303, 41FY14307, 41FY14308,
41FY14327, 41LV18477, 41LV18488, 41LV18495, 41GE52504,
41GE52505, 41GE52509, and 41GE52518;
d) Unit numbers: 41GP49366, 40P77131, 40P77137, 41FP32360,
41FP32370, 11LM04612, and 41GP49369 (distributed as
two split units);
e) Unit numbers: 12FR69999, 12FR70100, 12FR70228, 12FS95800,
12FS95805, 12FV98070, 12FY62776, 12FY62777, 12FY62779,
and 12FY62782;
f) Unit numbers: 11GM33526, 11GR09980, 11GW18760, 11GW18766,
11GW19331, 11GZ19790, 27LN00467, 27LQ1386, 27LQ1468,
27LR03037, 27LR03071, 27LR03252, 27LR03258, 27LS01010,
27LT01250, 27LT01292, 27LT01295, 27LT01301, 27LT01305,
27LT01308, 27LT01310, 27LT01315, 27LT01325, 27LT01329,
27LT01336, 27LT01339, 27LT01369, 27LX00961, 27LX00967,
27LX00968, 27LX00972, and 27LX01013
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Huntsville, AL, by telephone on July 24, 2000. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
AL

_______________________________
PRODUCT
Source Plasma, Recall # B-1719-5
CODE
Unit numbers 6270290460, 6270288321, 6270281906, and 6270280587
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on December 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1723-5
CODE
Unit number: 49GN32144
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on June 28, 2004, and by letter on July 1, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with Propionibacterium acnes bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Source Plasma, Recall # B-1746-5
CODE
Unit number: YP172848
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1784-5;
b) Fresh Frozen Plasma, Recall # B-1785-5;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-1786
CODE
a) Units 71L576324 and 71L515214;
b) Units 71L576324;
c) Unit 71W573436
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by telephone on January 31 and February 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for the antibody to the human T-lymphotropic virus (anti-HTLV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL and AL

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1821-5
CODE
Unit number: LR06615
RECALLING FIRM
San Diego Blood Bank, San Diego, CA, by telephone on September 29, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) DISCOVERY pacemaker (model nos. 1174, 1175, 1273,
1274 and 1275). Recall # Z-1032-05;
b) MERIDIAN pacemaker (model nos. 476, 976, 1176 and
1276), Recall # Z-1033-05;
c) PULSAR and PULSAR MAX (model nos. 470, 870, 970,
972, 1170, 1171, 1172, 1270 and 1272) pacemaker,
Recall # Z-1034-05;
d) PULSAR MAX II (model nos. 1180, 1181 and 1280)
pacemaker, Recall # Z-1035-05;
e) DISCOVERY II (model nos. 481, 981 1184, 1186, 1187,
1283, 1284, 1285 and 1286) pacemaker,
Recall # Z-1036-05;
f) VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker,
Recall # Z-1037-05;
g) INTELES II (model nos. 1349, 1384, 1385, 1483,
1484, 1485 and 1499) pacemaker, Recall # Z-1038-05;
h) CONTAK TR (model no. 1241) pacemaker,
Recall # Z-1039-05
CODE
a) Model 1174: Serial numbers 109017 thru 115660,
Model 1175: Serial numbers 200731 thru 202199,
Model 1273: Serial numbers 315516 thru 324528,
Model 1274: Serial numbers 296080 thru 496546,
Model 1275: Serial numbers 500705 thru 501661;
b) Model 476: Serial numbers 103316 thru 106064,
Model 976: Serial numbers 202612 thru 205357,
Model 1176: Serial numbers 303330 thru 306689,
and Model 1276: Serial numbers 404640 thru 409060;
c) Model 470: Serial numbers 101150 thru 101894,
Model 870: Serial numbers 200201 thru 201205,
Model 970: Serial numbers 300808 thru 301676,
Model 972: Serial numbers 452959 thru 454562,
Model 1170: Serial numbers 100610 thru 103665,
Model 1171: Serial numbers 300733 thru 302575,
Model 1172: Serial numbers 594273 thru 594437,
Model 1270: Serial numbers 595951 thru 608303,
Model 1272: Serial numbers 600250 thru 600749;
d) Model 1180: Serial numbers 100001 thru 100055,
Model 1181: Serial numbers 300001 thru 300050,
Model 1280: Serial numbers 500003 thru 500525;
e) Model 481: Serial numbers 100000 thru 100115,
Model 981: Serial numbers 200002 thru 200041,
Model 1184: Serial numbers 300012 thru 300061,
Model 1186: Serial numbers 500000 thru 500054,
Model 1187: Serial numbers 450000 thru 450010,
Model 1283: Serial numbers 600001 thru 600073,
Model 1284: Serial numbers 700000 thru 700079,
Model 1286: Serial numbers 900000 thru 900059;
f) Model 1380: Serial numbers 100000 thru 100044,
Model 1480: Serial numbers 500005 thru 500072;
g) Model 1349: Serial numbers 100003 thru 100076,
Model 1384: Serial numbers 300000 thru 300073,
Model 1385: Serial numbers 400005 thru 400019,
Model 1483: Serial numbers 600005 thru 600082,
Model 1484: Serial numbers 700005 thru 700064,
Model 1485: Serial numbers 800005 thru 800053,
Model 1499: Serial numbers 200001 thru 200073;
h) Serial numbers 200128 thru 200479
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated July 18, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
VOLUME OF PRODUCT IN COMMERCE
34,026
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Nichols Advantage ACTH Test System, catalog number 62-7004, Recall # Z-1044-05
CODE
Lot numbers: 62-500040 and 62-404296
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clemente, CA, by letters on April 22 and 29th, 2005. Firm initiated recall is ongoing.
REASON
Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
VOLUME OF PRODUCT IN COMMERCE
1,599
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Ohmeda Medicalís Giraffe’ OmniBeds and Giraffe Incubators, Recall # Z-1047-05
CODE
Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367
RECALLING FIRM/MANUFACTURER
Ohmeda Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by letter on April 25, 2005. Firm initiated recall is ongoing.
REASON
Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
VOLUME OF PRODUCT IN COMMERCE
788 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK
Material Number M001PIC402CK0, Recall # Z-1049-05;
b) PICC Catheter - 4.5 Fr Dual Lumen Catalog #PIC402CKIR,
Material Number M001PIC402CKIRO, Recall # Z-1050-05;
c) PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog
#PIC402CKMS, Material Number M001PIC402CKMSO,
Recall # Z-1051-05;
d) PICC Custom Kit GENESIS MEDICAL CENTER,
4.5F Dual Lumen, Catalog #60M120522.
UPN M00160M1205220, Recall # Z-1052-05
CODE
a) 917971, 921390, 926395, 926672, 928269;
b) 919488, 924206;
c) 925620;
d) 898659, 899145;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letters dated March 5, 2004.
Manufacturer: Boston Scientific Corp, Glens Falls, NY. Firm initiated recall is complete.
REASON
Lumens may have incorrect lumen size marked on them. The smaller capacity proximal fitting is on the larger handling volume lumen and the larger capacity proximal fitting on the smaller handling lumen. This may result in a slower rate of infusion.
VOLUME OF PRODUCT IN COMMERCE
242 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) BD Syringes - #309585 -- Piston Syringe,
Syringe 3ML LL Syringe. Recall # Z-1053-05;
b) # 309603 -- Syringe 5Ml LL syringe,
Recall # Z-1054-05;
c) # 309604 -- Syringe 10 mL LL, Recall # Z-1055-05;
d) #309661 -- Syringe only ll 20 mL, Recall # Z-1056-05;
e) #309644 -- 10 ml syringe with 20 G1' Needle,
Recall # Z-1057-05;
f) #309604 -- 10 mL syringe, Recall # Z-1058-05
CODE
a) Affected Lot 309585 Syringe 3ML LL
Syringe only Lot 5064003;
b) 309603 Syringe 5ML LL Syringe only 5067050,
309603 Syringe 5ML LL Syringe only 5062940;
c) 309604 Syringe 10 ML LL 5063484,
309604 Syringe 10 ML LL 5063495,
309604 Syringe 10 ML LL 5055564,
309604 Syringe 10 ML LL 5055567,
309604 Syringe 10 ML LL 5063493;
d) 309661 Syringe only LL 20 ML 5061527,
309661 Syringe only LL 20 ML 5047172;
e) 309644 10 mL Syringe with 20 Glî needle 5033890;
f) 309604 10 mL Syringe 5074833
RECALLING FIRM
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by telephone and letter on May 25, 2005.
Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.
REASON
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
VOLUME OF PRODUCT IN COMMERCE
3,857,760 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Mammomat Novation Digital Mammography System. Model number 646900, Recall # Z-1045-05
CODE
Serial numbers 1001, 1009, 1019, 1020, 1021, 1024, 1035, 1038, 1039, 1044, 1045, 1046, 1047, 1051, 1052, 1054, 1055, 1058, 1060, 1063, 1064, 1105, 1107, 1108, 1114, 1208, 1209, 1210, 1211, 1212, 1214, 1216, 1217, 1220, 1224, 1227, 1228, 1229, and 1234.
RECALLING FIRM/MANUFACTURER
Recalling firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters on June 10, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Potential issue (image acquisition may become interrupted) when using multiple network nodes.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Baxter Interlink System Huber Needle Extension Set; a sterile 10î fluid pathway with an Interlink Y --Injection Site and ¾î x 22 gauge needle, Recall # Z-1048-05
CODE
Lot number: FC04058
RECALLING FIRM
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter dated May 31, 2005.
Manufacturer: Command Medical Products, Ormond Beach, FL. Firm initiated recall is ongoing.
REASON
Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.
VOLUME OF PRODUCT IN COMMERCE
4,850 units
DISTRIBUTION
AK, FL, TX, NC, WI and Japan

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Pennitracin MD 50 G, Bacitracin Methylene Disalicylate, Type A Medicated Article, Antibacterial, each pound contains feed grade bacitracin methylene disalicylate equivalent to 50 grams bacitracin (Master Standard), For Manufacturing Registered Poultry and Livestock Feeds, NADA 141-137, packaged in 50-lb. bags. Recall # V-094-5
CODE
All lot numbers within expiration
RECALLING FIRM/MANUFACTURER
Pennfield Oil Co., Omaha, NB, by faxed letter dated November 22, 2004. Firm initiated recall is complete.
REASON
Stability testing at 24 months found the product does not meet the potency specifications.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,197,450 lbs.
DISTRIBUTION
Nationwide and Israel

_______________________________
PRODUCT
Silver Moon Feeds Complete Turkey 24% C Bites Medicated, Product #1643P, containing 100g/ton oxytetracycline and 70 g/ton neomycin base, packaged in 50-lb. bags or in bulk. Recall # V-095-5.
CODE
All product that does not bear the withdrawal time on the label
RECALLING FIRM/MANUFACTURER
Milbank Mills Inc., Chillicothe, MO, by letters dated June 8, 2005. Firm initiated recall is complete.
REASON
Label lacked withdrawal time.
VOLUME OF PRODUCT IN COMMERCE
6 tons bulk feed and 231/50-lb. bags
DISTRIBUTION
MO

END OF ENFORCEMENT REPORT FOR AUGUST 3, 2005

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