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U.S. Department of Health and Human Services

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Enforcement Report for May 18, 2005

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.

May 18, 2005
05-20

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Golden Lion® Dried Ziziphus Jujuba Mill, net wt. 12 oz. (340g). Product is a dried Chinese red dates packed in a sealed flexible plastic bag. Recall # F-280-5.
CODE
Barcode # 7 34765 04061 1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import Inc., Brooklyn, NY, by press release on October 8, 2004. Manufacturer: Daxin Huafeng Food Co. Ltd., Taishan, China. Firm initiated recall is complete.
REASON
Sampling and analysis by the New York State Department of Agriculture & Markets revealed that the product contained undeclared sulfites (290 ppm).
VOLUME OF PRODUCT IN COMMERCE
72 cases (50 -- 12 oz. packages per case).
DISTRIBUTION
NY, NJ, GA, NC, MD and D.C.

_______________________________
PRODUCT
a) Ziyad Brand Imported Tahini; sesame seed paste packaged
in 16 oz., UPC 74265-00156; 32 oz. UPC 74265-00155
(12 jars per case); 64 oz. glass jars, (6 jars per
case), UPC 74265-00307; and 128 oz. (4 jars per case)
plastic jars, UPC 74265-00093. Recall # F-281-5;
b) Ghandour Tahina 100% Crushed Sesame Seeds; sesame paste
packaged in 640 oz. (40 lb.) white plastic pails with
green lids and a wire handle; Product of Lebanon.
No UPC codes on the containers. Recall # F-282-5.
CODE
There are no lot numbers on the containers. All sizes of all products labeled as Ziyad Brand Imported Tahini are under recall.
RECALLING FIRM/MANUFACTURER
Syrian Bakery Company, Inc., D.B.A., Ziyad Brothers Importing, Cicero, IL, by press release dated April 11, 2005. Firm initiated recall is ongoing.
REASON
Tahini was found contaminated with Salmonella by the Minnesota Dept. of Agriculture, the Illinois Dept. of Public Health, and the FDA.
VOLUME OF PRODUCT IN COMMERCE
35,868 jars and 237 pails.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Smoked Atlantic Salmon in 4 oz, 8 oz, 12 oz,
16 oz and larger packages. All flavored varieties
listed below were manufactured from the same lot
of salmon and various expiration dates.
Recall # F-284-5;
b) Moroccan Salmon, one of the flavored varieties.
Recall # F-285-5;
c) Smoked Salmon Scampi, one of the flavored
varieties. Recall # F-286-5;
d) Salmon Bacon, one of the flavored varieties.
Recall # F-287-5;
e) Ming Tsai's 5-Spice Chile Tea Rub Smoked Salmon,
one of the flavored varieties. Recall # F-288-5;
f) Salmon Gravelox, one of the flavored varieties.
Recall # F-289-5;
g) Czar Cut Salmon Tenderloin. Recall # F-290-5;
h) Pastrami Salmon, one of the flavored varieties.
Recall # F-291-5.
CODE
a)- h) Lot 4328 of bulk salmon manufactured into various
flavors labeled as Lot 4328 and various expiration
dates listed below: 1/29/05, 1/30/05; 1/31/05;
2/01/05; 2/02/05; 2/03/05;
RECALLING FIRM/MANUFACTURER
Perona Farms Food Specialties, Inc., Andover, NJ, by telephone on January 7, 2005, and by letters on January 10, 2005. Firm initiated recall is ongoing.
REASON
One lot of Smoked Atlantic Salmon was positive for Listeria monocytogenes based on the Florida Department of Agriculture and Consumer Services' analysis.
VOLUME OF PRODUCT IN COMMERCE
250 fish equivalent to 500 sides.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Ham and Cheese, Sandwiches, sold packaged under
Fay's Triangle package and Fay's Foods label
and also under the Just For You label as a
Triple Halves and Just For You Golden Cut variety.
Recall # F-293-5;
b) Club Sandwiches, sold under Fay's Foods Triangles
and Just For You Triple Halves labeling.
Recall # F-294-5;
c) Turkey, Ham and Cheese sandwich under Fay's Foods
Triangle packaging/label. Recall # F-295-5;
d) Beef and Cheese Sandwich under Fay's Foods
Triangles label. Recall # F-296-5;
e) Turkey Breast Sandwich under Fay's Foods
Triangles label. Recall # F-297-5;
f) Tuna Salad Sandwich under both Fay's Foods
Triangles and Just For You Triple Halves label.
Recall # F-298-5;
g) Chicken Salad Sandwich, Fay's Triangle and
Just For You Triple Halves labels. Recall # F-299-5;
h) Egg Salad Sandwich, Fay's Triangle and
Just For You Triple Halves labels. Recall # F-300-5;
i) Fay's Croissant, Pastrami. Recall # F-301-5;
j) Fay's Croissant Ham and Cheese. Recall # F-302-5;
k) Fay's Croissant Turkey Breast. Recall # F-303-5;
l) Fay's Croissant Tuna Salad. Recall # F-304-5;
m) Fay's Breakfast Croissant. Recall # F-305-5;
n) Fay's French Roll/Bun, Turkey and Cheese.
Recall # F-306-5;
o) Fay's French Roll/Bun; Ham and Cheese.
Recall # F-307-5;
p) Fay's French Roll/Bun; Submarine. Recall # F-308-5;
q) Fay's French Roll/Bun; Pastrami and Cheese.
Recall # F-309-5;
r) Fay's French Roll/Bun; Beef & Jalapeno.
Recall # F-310-5;
s) Fay's French Roll/Bun; BBQ Chicken. Recall # F-311-5;
t) Fay's French Roll/Bun; Italian Meatball.
Recall # F-312-5;
u) Fay's French Roll/Bun; BBQ Beef. Recall # F-313-5;
v) Fay's French Roll/Bun; Polish Sausage.
Recall # F-314-5;
w) Fay's French Roll/Bun; Double Cheese Dog.
Recall # F-315-5;
x) Fay's French Roll/Bun; Cheese Burger. Recall # F-316-5;
y) Fay's and Just For You Pasta Salad; Tuna Mac.
Recall # F-317-5;
z) Fay's and Just For You Pasta Salad; Cajun Chicken.
Recall # F-318-5;
aa) Fay's and Just For You Salads; Chef. Recall # F-319-5;
bb) Fay's and Just For You Salad; Chicken Ceasar.
Recall # F-320-5;
cc) Fay's and Just For You Salad; Vegetable Plate.
Recall # F-321-5;
dd) Fay's Salads; Cajun Chicken Salad. Recall # F-322-5;
ee) Fay's One of the Kind Bagel and Cream Cheese.
Recall # F-323-5;
ff) Fay's One of the Kind Double Egg Cup with Cheese.
Recall # F-324-5;
gg) Just For You Tuna Salad. Recall # F-325-5;
hh) Just For You Pasta; Tomato Garlic. Recall # F-326-5;
ii) Just For You Pasta; Spinach and Cheese.
Recall # F-327-5;
jj) Just For You Pasta; Country Chicken. Recall # F-328-5;
kk) Just For You Triple Halves Sandwich; Turkey and Cheese.
Recall # F-329-5;
ll) Just For You Golden Cut Sandwich; Turkey and Swiss.
Recall # F-330-5;
mm) Just For You Golden Cut Sandwich; Submarine.
Recall # F-331-5;
nn) Just For You Golden Cut Sandwich; Beef and Jalapeno.
Recall # F-332-5;
oo) Just For You Golden Cut Sandwich; Pastrami and Swiss.
Recall # F-333-5;
pp) Just For You Golden Cut Sandwich; Giant Grinder.
Recall # F-334-5;
qq) Just For You Croissant, Turkey and Swiss.
Recall # F-335-5;
rr) Just For You Pitas; Ham and Cheese. Recall # F-336-5;
ss) Just For You Pitas; Turkey and Swiss.
Recall # F-337-5;
tt) Just For You Pitas; Beef and Cheese. Recall # F-338-5;
uu) Just For You Pitas; Roast Chicken. Recall # F-339-5;
vv) Just For You Health Nut Sandwich; Turkey and Swiss.
Recall # F-340-5;
ww) Just For You Health Nut Sandwich; Tuna and Swiss.
Recall # F-341-5;
xx) Just For You Focaccia; Turkey and Swiss.
Recall # F-342-5;
yy) Just For You Focaccia; Ham and Cheese. Recall # F-343-5.
CODE
Julian code of 05003 through 05049 stamped on the bottom of containers.
RECALLING FIRM/MANUFACTURER
Fay's Foods, Inc., North Hollywood, CA, by telephone, hand-bill and press release on February 19, 2005. Firm initiated recall is complete.
REASON
These ready-to-eat foods may be contaminated with Listeria monocytogenes based on FDA's analysis of several samples.
VOLUME OF PRODUCT IN COMMERCE
Uncertain.
DISTRIBUTION
CA.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
______________________________

PRODUCT
Cedar brand Chick Peas Dip (Hummus Tahina), in 24/13 oz metal cans per case. Product of Lebanon. Recall # F-279-5.
CODE
Prod 9/2003, Exp 9/2005 on the bottom of the can.
RECALLING FIRM/MANUFACTURER
Dpi Mid Atlantic, Upper Marlboro, MD, by e-mail and telephone on August 4, 2004. Firm initiated recall is complete.
REASON
Product may not have been adequately acidified to control pathogens.
VOLUME OF PRODUCT IN COMMERCE
21 cases.
DISTRIBUTION
MD, VA, and D.C.

_______________________________
PRODUCT
Nature's Plus® The Energy Supplements® --- HERBAL ACTIVES --- KOREAN GINSENG --- 250 MG/15% GINSENOSIDES --- STANDARDIZED BOTANICAL SUPPLEMENT --- MAXIMUM GUARANTEED POTENCY --- PRESCRIPTION QUALITY --- 60 CAPSULES --- PRODUCT NO. 7216. The product is a clear gelatin oval capsule contained in a 60 count white plastic bottle with an inner seal; Bottle contains an insert. Bar code # 0 97467 07216 9. Recall # F-344-5.
CODE
Lots: 1047806, 1052379, 1056527, 1067219, 1076347.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Organics, Melville, NY, by letters dated March 24, 2005.
Manufacturer: Natural Organics Laboratories, Inc., Amityville, NY. Firm initiated recall is ongoing.
REASON
Raw material ginseng extract and bulk ginseng capsules were found to be contaminated with pesticides based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
2,397 bottles.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Celery root, packed 12 in a generic produce box. Recall # F-345-5.
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Trapold Farms, Portland, OR, by telephone on March 7, 2005. Firm initiated recall is complete.
REASON
The product contains linuron pesticide residue.
VOLUME OF PRODUCT IN COMMERCE
638 cases, each containing 12.
DISTRIBUTION
OR, and WA.

_______________________________
PRODUCT
Bandara candy, 2.25 lbs., 22 pieces. Recall # F-346-5.
CODE
Unknown.
RECALLING FIRM/MANUFACTURER
LaZamorana Candy Company, Inc., Los Angeles, CA, by telephone and fax on March 25, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors, FD&C Yellow #5, Red #40, and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
550.
DISTRIBUTION
FL, AZ, UT, CA, and OR.

_______________________________
PRODUCT
a) 4 varieties of dry brownie mix and 11 varieties of
frozen cookie dough mix. Super Chocolate Chunk dry
brownie mix Elliotts Fort Benton, Mt Country Brownie
Mix Net Wt. 40 oz. plastic lined paper bags.
Recall # F-347-5;
b) Chunky Walnut Chocolate dry brownie mix in 40 oz.
plastic lined paper bags labeled ELLIOTTS Fort Benton,
Mt Country Brownie Mix. Recall # F-348-5;
c) Minty Chocolate Chunk dry brownie mix in 40 oz.
plastic lined paper bag labeled ELLIOTTS Fort Benton,
Mt Country Brownie Mix. Recall # F-349-5;
d) Toffee Candy Chocolate Chunk dry brownie mix in 40 oz.
plastic lined paper bags labeled ELLIOTTS Fort Benton,
Mt. Country Brownie Mix. Recall # F-350-5;
e) Country Chocolate Chip frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-351-5;
f) Peanut Butter Pleasure frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-352-5;
g) Sugar Delights frozen cookie dough in 3 lb. plastic tub
labeled ELLIOTTS Fort Benton, Mt. Country Cookie Dough.
Recall # F-353-5;
h) Lemon Poppy Seed frozen cookie dough in 3 lb. plastic
tub labeled ELLIOTTS Fort Benton, Mt. Country Cookie
Dough. Recall # F-354-5;
i) Oatmeal Raisin Chews frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # 355-5;
j) Cookie Jar Gingersnaps frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-356-5;
k) Macadamia White Chocolate Lace frozen cookie dough in
3 lb. plastic tub labeled ELLIOTTS Fort Benton, Mt.
Country Cookie Dough. Recall # F-357-5;
l) Chocolate Mint Brownie frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-358-5;
m) Chewy Oatmeal Chocolate Chunk frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-359-5;
n) Chunky Chocolate Heath frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-360-5;
o) MMM Monster Cookies frozen cookie dough in 3 lb.
plastic tub labeled ELLIOTTS Fort Benton, Mt. Country
Cookie Dough. Recall # F-361-5.
CODE
Products are not coded.
RECALLING FIRM/MANUFACTURER
Elliot's Pasta, Fort Benton, MT, by telephone on March 31, 2005, and by letter on April 4, 2005. Firm initiated recall is complete.
REASON
These products do not bear any ingredient statement and contain undeclared colors or allergens including wheat flour, milk, peanuts, tree nuts and eggs.
VOLUME OF PRODUCT IN COMMERCE
4,662/3 lb tubs frozen cookie dough;
464/40 oz. packages cookie mix.
DISTRIBUTION
MT.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
Neurontin Capsules (Gabapentin), 100 mg 100 count bottles, Rx only, NDC 0071-0803-24. Recall # D-227-5.
CODE
Lot 15224V, Expiration 08/2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., NY, NY, by fax, voice broadcast and press release on April 22, 2005. Firm initiated recall is ongoing.
REASON
Subpotent; some capsules may be empty or partially filled.
VOLUME OF PRODUCT IN COMMERCE
40,101.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

______________________________
PRODUCT
Adderall XR (Mixed Salts of a Single Entity Amphetamine Product) Extended Release Capsules 20mg 100 Capsules, Rx only. Each capsule contains: Dextroamphetamine Sacccharate 5.0mg, Dextroamphetamine Sulfate USP 5.0mg: Amphetamine Sulfate USP 5.0mg, total amphetamine base equivalence 12.5mg. Recall # D-152-5.
CODE
Lot # A00819A.
RECALLING FIRM
Recalling Firm: Shire Us Inc., Newport, KY, by fax on/about January 6, 2005.
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
Mislabeling: Adderall XR 30 mg capsules were found within one bottle labeled Adderall XR 20 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
10,919 bottles (100 capsules per bottle).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Fluorescite 10% Injection, 100mg/ml fluorescein, 5 mL Sterile, Rx only. Recall # D-220-5.
CODE
Lot numbers: Z13048, Z13051, Z13052, Z13123, and Z13124.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by letter on March 9, 2005.
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility.
VOLUME OF PRODUCT IN COMMERCE
Approximately 5,000 units.
DISTRIBUTION
Japan, Canada, Germany, Austria, and Korea.

_______________________________
PRODUCT
Cortisporin Ophthalmic Suspension, Sterile, (neomycin and polymyxin B. sulfates and hydrocortisone ophthalmic suspension, USP, Each mL contains neomycin sulfate equivalent to 3.5mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, hydrocortisone 10 mg (1%), 7.5mL bottle, Rx only, NDC 61570-036-75. Recall # D-221-5.
CODE
Lot numbers: 211802, Exp. 07/05 and A04162, Exp. 06/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on March 15, 2005.
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
Subpoten (hydrocortisone, 6 month stability).
VOLUME OF PRODUCT IN COMMERCE
36,475 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Intravenous Sodium Edecrin (Ethacrynate Sodium) 50 mg single use vial, Rx only. NDC 0006-3620-50. Recall # D-223-5.
CODE
Lot # 1045P Exp. 2/28/06 and Lot # 0127R Exp. 3/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck & Co, Inc., Merck Manufacture, West Point, PA, by letters dated April 11, 2005 and May 4, 2005.
Manufacturer: Ben Venue Laboratories, Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
6,983 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection. Recall # D-224-5.
CODE
Lot number: 3847M Exp. October 1, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Medical Imaging, Inc., North Billerica, MA, by letter on March 25, 2005 and April 19, 2005.
Manufacturer: Bristol Myers Squibb Holdings Pharma., Ltd., Manati, PR. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility (Vial seal integrity).
VOLUME OF PRODUCT IN COMMERCE
18,495 vials.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Premarin (conjugated estrogen tablets, USP), 0.3 mg, packaged in 100 tablet size bottles, containing NDC 0046-0868-81 (AYERST). Recall # D-222-5.
CODE
Lot 030793, Exp. July 31, 2005.
RECALLING FIRM
Recalling Firm: Amerisource Health Services, Columbus, OH, by letter, dated April 12, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
5,395/100 tablet bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Tylenol Acetaminophen Extended Release Arthritis Pain, for the temporary relief of minor arthritis pain. Retail carton dispenser: Acetaminophen 250 mg, Retail individual pouch: Acetaminophen 650 mg. Recall # D-225-5.
CODE
Lot Number JCM044.
RECALLING FIRM/MANUFACTURER
Select Distributors, Inc, Dallas, TX, by telephone on February 28, 2005 and March 1, 2005. Firm initiated recall is complete.
REASON
Mislabeling: Retail dispensing carton indicates wrong strength of Acetaminophen but retail pouches are labeled with proper strength.
VOLUME OF PRODUCT IN COMMERCE
1,250 Cartons containing 50 pouches.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

*****CORRECTION*****

In the April 14, 2004, Enforcement Report (04-15), Class II, Recall # B-1072-4, Red Blood Cells, Leukocytes Reduced, the correction is a Unit Number Addition: 21GL83385.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0963-5.
CODE
Unit: 26KE44577.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Gulf Coast Region, Mobile, AL, by letter dated July 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1008-5.
CODE
Unit: 4525832.
RECALLING FIRM
Northern California Community Blood Bank, Eureka, CA, by facsimile on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA..
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1025-5.
CODE
Units: 6792683, 7002628.
RECALLING FIRM
Carter Blood Care, Bedford, TX, by telephone on August 26 and 27, 2004, and by letters dated September 10 and October 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet minimum weight requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1041-5.
CODE
Unit numbers: 116065, 117073, 117155, 117455, 117698, 117937, 118136, 118511, 118690, 118936, 119160, 119378, 337561, 337823, 338093, 338238, 388108, 388291, 388655, 388718, 389216, and 389383.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, San Angelo, TX, by facsimile on February 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.        
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1042-5.
CODE
Unit numbers: 118443, 118619, 119019, 119156, 119473, 337554, 337904, 337997, 388204, 388278, 388602, 388700, 388995, 389130, and 389505.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, San Angelo, TX, by facsimile on February 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.        
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recal # B-1043-5.
CODE
Units: 6270288440, 6270287649, 6270286890.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Salt Lake City, UT, by facsimile dated January 3, 2003. Firm initiated recall is complete.                
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1049-5;
b) Fresh Frozen Plasma. Recall # B-1050-5.
CODE
a) and b) Unit number: 06GJ78639.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern California Region, Pomona, CA, by letters, dated March 24, 2004 and April 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1051-5;
b) Recovered Plasma. Recall # B-1052-5.
CODE
a) and b) Unit number: 06GK44104.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern California Region, Pomona, CA, by facsimile on June 4, 2004, and by letter, dated June 11, 2004. Firm initiated recall is complete.
REASON
Blood products tested negative for viral markers but were collected from an ineligible donor due to risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1062-5.
CODE
Unit numbers: 388131, 388192, 388604, 388876, 389011, 389292, and 389482.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, San Angelo, TX, by facsimile on February 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Whole Blood for Manufacturer of Non-Injectables. Recall # B-1063-5.
CODE
Unit EC005058.
RECALLING FIRM/MANUFACTURER
Knoxville Plasma Corporation, Knoxville, TN, by telephone on March 11, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1064-5.
CODE
Unit number: 398834.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, San Angelo, TX, by facsimile on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1067-5.
CODE
Unit 26FF43919.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Gulf Coast Region, Mobile, AL, by telephone on May 24, 2001. Firm initiated recall is complete.
REASON
Blood product, which tested positive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1069-5.
CODE
Unit number: 3186322.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on March 24, 1999. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a recent blood product transfusion, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets Pheresis, Irradiated. Recall # B-1071-5.
CODE
Unit number 19LP03488.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter on July 25, 1997. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1073-5.
CODE
Unit number: 2823825.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on September 6, 2000. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1091-5.
CODE
Unit number: 03RMIC7845.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, L.P., Grand Rapids, MI, by facsimile on February 30, 2005. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1094-5.
CODE
Unit numbers: 360022030 and 360023905.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1096-5;
b) Platelets. Recall # B-1097-5;
c) Recovered Plasma. Recall # B-1098-5.
CODE
a), b), and c) Unit number: 4556254.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on February 24, 2003, and March 26, 2003, and by letter on April 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OK, TX, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1099-5.
CODE
Unit numbers 66171942 and 66169307.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on June 12, 2002.
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1100-5.
CODE
Unit numbers: 81359073, 81344802, 81323296, 81319046, 81295418, 81289110, 81282685, 81260539, 81255771, 81252503, and 81243372.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on December 3, 2002.
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1101-5.
CODE
Unit numbers: 81313570 and 66206521.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on December 18, 2002.
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1102-5.
CODE
Corneas numbers CT200502-6-2-R-01 and CT200502-6-2-L-01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD, by facsimile and letter on March 2, 2005.
Manufacturer: Connecticut Eye Bank and Visual Research Foundation, Inc., New Britain, CT. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Italy.

_______________________________
PRODUCT
Source Plasma. Recall # B-1103-5.
CODE
Unit numbers 01BMTA4766, 01BMTA2437, 01BMTA1228, 01BMTA0943, and 01BMTA0728.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P. Deerfield, IL, by facsimile on August 22, 2002.
Manufacturer: BioLife Plasma Services L.P., Billings, MT. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1104-5.
CODE
Unit number 38J52107.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on February 17, 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
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1105-5.
CODE
Units 6270288602, 6270287728.      
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Salt Lake City, UT, by facsimile on December 31, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1106-5.
CODE
Unit number: 301858029.      
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 7, 2003.
Manufacturing Firm: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for Cytomegalovirus (CMV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ND.

_______________________________
PRODUCT
Source Plasma. Recall # B-1107-5.
CODE
Unit numbers: SW078409, SW078919, SW079683, SW079964.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, Deerfield, IL, by facsimile on May 23, 2003.
Manufacturer: BioLife Plasma Services, Seattle, WA. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the receipt of tattoos and body piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1108-5.
CODE
Unit numbers 360006619, 360006901, 360007404, 360007682, 360008247, 360008549, 360009562, 360009793, 360011443, 360012052, 360012397, 360012693, 360013182, 360013621, 360014261, 360014605, 360015194, 360018471, 360018976, 360019646, 360020309, 360020449, 360020930, and 360021752.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on July 13, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that did not have the routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1109-5.
CODE
Unit number: F-10011-009.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., Tacoma, WA, by facsimile on March 13,2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on an unexplained weight loss, was distributed.         
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1110-5;
b) Recovered Plasma. Recall # B-1111-5.
CODE
a) and b) Unit number: 4503041.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 2, 2002, and March 27, 2003, and by letter on April 9, 2003. Firm initiated recall is complete.
REASON
Blood products collected from a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1112-5;
b) Fresh Frozen Plasma. Recall # B-1113-5.
CODE
a) Unit numbers: 18FT95844 and 18FT95847;
b) Unit number: 18FT95847.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on January 12, 2005, and by letter on January 13, 2005. Firm initiated recall is complete.
REASON
Blood products collected from a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1114-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-1115-5;
c) Platelets. Recall # B-1116-5;
d) Platelets, Irradiated. Recall # B-1117-5;
e) Platelets, Leukocytes Reduced.
Recall # B-1118-5;
f) Fresh Frozen Plasma. Recall # B-1119-5;
g) Recovered Plasma. Recall # B-1120-5.
CODE
a) Unit numbers 38KT00312 and 38KT10720 (4 split units);
b) Unit numbers 38FE89461, 38FE89487, 38FE89831,
38FE89876, 38H86598, 38H86889, 38H86910, 38H86927,
38H87310, 38H87542, 38H87626, 38H87684, 38H87749,
38H87771, 38H88128, 38H88260, 38H88264, 38H88289,
38H88305, 38H88351, 38H88510, 38H88741, 38H88873,
38H88974, 38H89019, 38H89048, 38H89063, 38H89066,
38H89070, 38H89079, 38H89084, 38H89090, 38H89112,
38H89309, 38H89348, 38H89399, 38H89402, 38H89492,
38H89515, 38H89556, 38H90129, 38H90171, 38H90313,
38H90496, 38H90692, 38H90756, 38H90811, 38H90816,
38H90904, 38H90970, 38H91058, 38H91236, 38H91258,
38H91283, 38H91444, 38H91620, 38H91798, 38H91869,
38H91948, 38H91970, 38H91986, 38H92022, 38H92063,
38H92080, 38H92356, 38H92432, 38H92454, 38H92462,
38H92464, 38H92613, 38H92623, 38H92624, 38H92625,
38H92651, 38H92659, 38H92686, 38H92739, 38H92880,
38H92908, 38H92918, 38H93088, 38H93111, 38H93122,
38H93129, 38H93135, 38H93262, 38H93404, 38H93467,
38H93539, 38H93547, 38H93661, 38H93749, 38H93772,
38H93775, 38H93792, 38H93845, 38H93980, 38H94097,
38H94108, 38H94119, 38H94454, 38H94484, 38H94503,
38H94524, 38H94530, 38H94531, 38H94554, 38H94597,
38H94647, 38H94722, 38H94734, 38H94735, 38H94742,
38H94748, 38H94749, 38H94753, 38H94755, 38H94763,
38H94770, 38H94891, 38H95078, 38H95109, 38H95166,
38H95204, 38H95506, 38H95743, 38H95920, 38H95928,
38H95956, 38H95983, 38H95994, 38H95996, 38H96006,
38H96012, 38H96022, 38H96024, 38H96111, 38H96173,
38H96205, 38H96400, 38H96405, 38H96497, 38H96661,
38H96843, 38H96959, 38H97005, 38H97249, 38H97327,
38H97353, 38H97450, 38H97685, 38H97869, 38H97882,
38H97900, 38H98140, 38H98196, 38H98213, 38H98274,
38H98368, 38H98695, 38H98803, 38H99506, 38H99509,
38H99518, 38H99592, 38KT00068, 38KT00098, 38KT00106,
38KT00108, 38KT00113, 38KT00133, 38KT00141, 38KT00142,
38KT00152, 38KT00155, 38KT00164, 38KT00176, 38KT00216,
38KT00220, 38KT00226, 38KT00232, 38KT00247, 38KT00254,
38KT00590, 38KT00607, 38KT00767, 38KT00814, 38KT00824,
38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159,
38KT01168, 38KT01207, 38KT01531, 38KT01747, 38KT01794,
38KT01860, 38KT02218, 38KT02420, 38KT02537, 38KT02630,
38KT02750, 38KT02782, 38KT02796, 38KT02857, 38KT02859,
38KT02860, 38KT02871, 38KT02883, 38KT02930, 38KT02948,
38KT02951, 38KT02955, 38KT03156, 38KT03208, 38KT03213,
38KT03363, 38KT03367, 38KT03371, 38KT03379, 38KT03380,
38KT03385, 38KT03389, 38KT03390, 38KT03392, 38KT03421,
38KT03475, 38KT03512, 38KT03520, 38KT03584, 38KT03598,
38KT03635, 38KT03925, 38KT03942, 38KT04229, 38KT04278,
38KT04603, 38KT04763, 38KT04790, 38KT04794, 38KT05046,
38KT05077, 38KT05090, 38KT05094, 38KT05242, 38KT05255,
38KT05461, 38KT05480, 38KT05489, 38KT05564, 38KT05777,
38KT06004, 38KT06054, 38KT06127, 38KT06191, 38KT06265,
38KT06267, 38KT06272, 38KT06300, 38KT06368, 38KT06398,
38KT06421, 38KT06424, 38KT06437, 38KT06469, 38KT06493,
38KT06607, 38KT06612, 38KT06630, 38KT06822, 38KT06905,
38KT07155, 38KT07725, 38KT07751, 38KT07881, 38KT07998,
38KT08007, 38KT08046, 38KT08204, 38KT08222, 38KT08240,
38KT08242, 38KT08272, 38KT08283, 38KT08522, 38KT08558,
38KT08682, 38KT08692, 38KT08739, 38KT08800, 38KT09049,
38KT09098, 38KT09109, 38KT09227, 38KT09307, 38KT09388,
38KT09561, 38KT09722, 38KT09732, 38KT09753, 38KT09755,
38KT09757, 38KT09758, 38KT09766, 38KT09768, 38KT09773,
38KT09778, 38KT09787, 38KT09791, 38KT09798, 38KT09805,
38KT09806, 38KT09809, 38KT09816, 38KT09817, 38KT09822,
38KT09850, 38KT10027, 38KT10148, 38KT10387, 38KT10426,
38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552,
38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633,
38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10924,
38KT10936, 38KT10964, 38KT10965, 38KT10972, 38KT10989,
38KT11005, 38KT11010, 38KT11037, 38KT11136, 38KT11437,
38KT11444, 38KT11553, 38KT11601, 38KT11787, 38KT11931,
38KT11943, 38KT11945, 38KT11966, 38KT11968, 38KT11984,
38KT12105, 38KT12115, 38KT12116, 38KT12127, 38KT12130,
38KT12132, 38KT12138, 38KT12142, 38KT12149, 38KT12339,
38KT12355, 38KT12391, 38KT12621, 38KT12810, 38KT13008,
38KT13025, 38KT13026, 38KT13104, 38KT13110, 38KT13138,
38KT13173, 38KT13306, 38KT13483, 38KT13580, 38KT13698,
38KT13710, 38KT13843, 38KT13859, 38KT13860, 38KT13862,
38KT13868, 38KT13898, 38KT13905, 38KT13923, and 38KT13980;
and the following units were distributed as two split
products: Unit numbers 38LC48030, 38H87730, 38KT13824,
38KT13364, 38KT12214, 38KT12215, 38KT12323, 38KT09801,
38KT08436, 38KT06358, 38KT06251, 38KT06172, 38KT06180,
38KT06000, 38KT03989, 38KT03617, 38KT03348, 38KT03350,
38KT03351, 38KT03352, 38KT01959, 38KT01257, 38KT00833,
38KT00737, 38H99159, 38H98325, 38H98149, 38H97253,
38H97095, 38H95990, 38H94800, 38H94767, 38H92548, and
38H91981;
c) Unit numbers 38H88128, 38H88741, 38H89399, 38H90496,
38H90904, 38H90388, 38H93129, 38H93135, 38H93980,
38H96400, 38H97882, 38H98695, 38KT00814, 38KT00824,
38KT01018, 38KT06607, 38KT06612, 38KT06630, 38KT07155,
38KT09388, 38KT09399, 38KT09561, 38KT10027, 38KT10148,
38KT10924, 38KT10936, 38KT10964, 38KT11931, and 38KT11966;
d) Unit number 38KT11968;
e) Unit numbers 38H89402, 38H94891, 38H98196, and 38H98213;
f) Unit numbers 38H86598, 38H87310, 38H88128, 38H88741,
38H89399, 38H89402, 38H89461, 38H90496, 38H90904,
38H93980, 38H94891, 38H96843, 38H97685, 38H97882,
38H98695, 38KT00814, 38KT00824, 38KT01747, 38KT03942,
38KT04603, 38KT04790, 38KT05480, 38KT05487, 38KT06612,
38KT06630, 38KT07155, 38KT09388, 38KT09561, 38KT09822,
38KT09850, 38KT10027, 38KT10148, 38KT10720, 38KT10924,
38KT10936, 38KT10964, 38KT11931, 38KT11943, 38KT11966,
38KT11968, 38KT12355, 38KT12621, and 38KT13173;
g) Unit numbers 38FE89461, 38FE89487, 38FE89831, 38FE89876,
38H86889, 38H86910, 38H86927, 38H87542, 38H87626,
38H87684, 38H87749, 38H87771, 38H88260, 38H88264,
38H88289, 38H88305, 38H88351, 38H88510, 38H88650,
38H88873, 38H88974, 38H89048, 38H89063, 38H89066,
38H89070, 38H89079, 38H89084, 38H89090, 38H89112,
38H89309, 38H89348, 38H89492, 38H89515, 38H89556,
38H90129, 38H90171, 38H90313, 38H90692, 38H90756,
38H90811, 38H90816, 38H90970, 38H91058, 38H91236,
38H91258, 38H91283, 38H91444, 38H91620, 38H91798,
38H91869, 38H91948, 38H91970, 38H91986, 38H92022,
38H92063, 38H92080, 38H92356, 38H92432, 38H92454,
38H92462, 38H92464, 38H92613, 38H92623, 38H92624,
38H92625, 38H92651, 38H92659, 38H92686, 38H92739,
38H92880, 38H92908, 38H92918, 38H93088, 38H93111,
38H93122, 38H93129, 38H93135, 38H93262, 38H93404,
38H93467, 38H93539, 38H93547, 38H93661, 38H93749,
38H93772, 38H93775, 38H93792, 38H93845, 38H94097,
38H94108, 38H94119, 38H94454, 38H94484, 38H94503,
38H94524, 38H94530, 38H94531, 38H94554, 38H94597,
38H94647, 38H94722, 38H94732, 38H94735, 38H94742,
38H94743, 38H94748, 38H94749, 38H94753, 38H94755,
38H94763, 38H94770, 38H95078, 38H95109, 38H95166,
38H95204, 38H95506, 38H95743, 38H95920, 38H95928,
38H95956, 38H95983, 38H95994, 38H95996, 38H96006,
38H96012, 38H96022, 38H96024, 38H96111, 38H96173,
38H96205, 38H96497, 38H96661, 38H96959, 38H97005,
38H97249, 38H97327, 38H97353, 38H97450, 38H97869,
38H97900, 38H98140, 38H98196, 38H98213, 38H98274,
38H98368, 38H98803, 38H99506, 38H99509, 38H99518,
38KT00068, 38KT00098, 38KT00106, 38KT00108, 38KT00113,
38KT00133, 38KT00141, 38KT00142, 38KT00152, 38KT00155,
38KT00164, 38KT00176, 38KT00216, 38KT00220, 38KT00226,
38KT00232, 38KT00247, 38KT00254, 38KT00590, 38KT00607,
38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159,
38KT01168, 38KT01207, 38KT01531, 38KT01794, 38KT01860,
38KT02218, 38KT02420, 38KT02537, 38KT02630, 38KT02750,
38KT02782, 38KT02796, 38KT02857, 38KT02859, 38KT02860,
38KT02871, 38KT02883, 38KT02930, 38KT02948, 38KT02951,
38KT02955, 38KT03156, 38KT03208, 38KT03213, 38KT03363,
38KT03367, 38KT03371, 38KT03379, 38KT03380, 38KT03385,
38KT03389, 38KT03390, 38KT03392, 38KT03421, 38KT03475,
38KT03512, 38KT03520, 38KT03584, 38KT03598, 38KT03635,
38KT03925, 38KT04229, 38KT04278, 38KT04763, 38KT04794,
38KT05046, 38KT05077, 38KT05086, 38KT05090, 38KT05094,
38KT05242, 38KT05255, 38KT05461, 38KT05489, 38KT05564,
38KT05777, 38KT06004, 38KT06054, 38KT06127, 38KT06191,
38KT06265, 38KT06267, 38KT06272, 38KT06300, 38KT06368,
38KT06398, 38KT06421, 38KT06424, 38KT06437, 38KT06469,
38KT06493, 38KT06607, 38KT06822, 38KT06905, 38KT07725,
38KT07751, 38KT07881, 38KT07998, 38KT08007, 38KT08046,
38KT08204, 38KT08222, 38KT08240, 38KT08242, 38KT08272,
38KT08283, 38KT08522, 38KT08558, 38KT08682, 38KT08692,
38KT08739, 38KT08760, 38KT08800, 38KT09049, 38KT09098,
38KT09109, 38KT09227, 38KT09307, 38KT09399, 38KT09722,
38KT09732, 38KT09753, 38KT09755, 38KT09757, 38KT09758,
38KT09766, 38KT09768, 38KT09773, 38KT09778, 38KT09787,
38KT09791, 38KT09798, 38KT09805, 38KT09806, 38KT09809,
38KT09816, 38KT09817, 38KT09933, 38KT10387, 38KT10426,
38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552,
38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633,
38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10965,
38KT10972, 38KT10989, 38KT11005, 38KT11010, 38KT11037,
38KT11136, 38KT11437, 38KT11444, 38KT11553, 38KT11555,
38KT11601, 38KT11787, 38KT11945, 38KT11984, 38KT12105,
38KT12115, 38KT12116, 38KT12127, 38KT12130, 38KT12132,
38KT12138, 38KT12142, 38KT12149, 38KT12339, 38KT12391,
38KT12810, 38KT13008, 38KT13025, 38KT13026, 38KT13104,
38KT13110, 38KT13138, 38KT13275, 38KT13301, 38KT13306,
38KT13483, 38KT13580, 38KT13698, 38KT13710, 38KT13843,
38KT13859, 38KT13860, 38KT13862, 38KT13868, 38KT13898,
38KT13905, 38KT13923, 38KT13929, 38KT13941, 38KT13980,
and 38KT14160.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone, facsimile, and letter between March 24, 2004, and May 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening did not include adequate questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
904 units.
DISTRIBUTION
AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland.
 

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced. Recall # B-0993-5.
CODE
Unit: 6029773.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on August 25, 2004, and by letter on June 15, 2004. Firm initiated recall is complete.
REASON
Blood products, processed in a centrifuge that had not had Quality Control testing performed, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1044-5.
CODE
Unit: S24936.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on November 30, 2004, and by letter dated January 26, 2005. Firm initiated recall is complete.
REASON
Blood product, lacking proper manufacturing documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1046-5;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1047-5;
c) Fresh Frozen Plasma. Recall # B-1048-5.
CODE
a) Units 053FE70643, 053GQ93574;
b) Units 053Y95499, 053FL05759, 053FC11286, 053GQ94217,
053GE70455, 053FH98091, 053FH98092;
c) Units 053R04687, 053FL05759, 053FC10882, 053FN86838,
053R04682, 053GE70458, 053FN86835, 053T98395, 053V09102,
053V09103, 053FE71448, 053FC10881, 053FC08856, 053FC10879,
053Q95086, 053GJ31776, 053R01074, 053FN86832, 053V09100,
053R05246.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Regions, Baltimore, MD, by facsimile on April 10, 2003 and May 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have been manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
MD, VA, and D.C.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1068-5.
CODE
Unit numbers: 7167094 and 7167480.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 22, 1999. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1070-5.
CODE
Unit number: 19LE17867.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter on October 8, 1999. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1072-5.
CODE
Units: 30186-8032, 30186-8033, 30186-8035, 30186-7952, and 30186-7955.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on August 6, 2003.
Manufacturer: Blood Systems, Inc, Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MN, and ND.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1090-5.
CODE
Unit number: 7799146.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on January 26, 2005. Firm initiated recall is complete.
REASON
Platelets Pheresis were not tested for platelet count.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-1092-5.
CODE
Unit number: 18FW59516.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone and letter on February 10, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1093-5.
CODE
Unit number: 18FT96634.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on January 11, 2005, and by letter on January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads "PART # 920650 ADAPTER CM100/LMC ELECTRODE". There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack. Recall # Z-0805-05.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Laerdal Medical Corporation, Wappingers Falls, NY, by press release on April 28, 2005, and by letters on April 29, 2005.
Manufacturer: Volex Inc., North Dartmouth, MA. Firm initiated recall is ongoing.
REASON
Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
VOLUME OF PRODUCT IN COMMERCE
Approximately 3,019.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part number 972200E. Recall # Z-0806-05.
CODE
Serial numbers 201887, 204213, 205309, 205857, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 206073, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206094, 206096, 206097, 206098, 206101, 206111, 206112, 206113, 206114, 206115, 206116, 206117, 206118, 206119, 206120, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206146, 206147, 206149, 206150, 206151, 206152, 206153, 206154, 206159, 206160, 206162, 206163, 206164, 206165, 206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176, 206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186, 206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196, 206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206, 206207, 206208, 206209, 206210, 206212, 206213, 206214, 206215, 206216, 206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226, 206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236, 206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246, 206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256, 206257, 206258, 206259, 206260, 206261, 206262, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206284, 206285, 206286, 206287, 206289, 206290, 206291, 206292, 206293, 206294, 206295, 206296, 206297, 206298, 206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308, 206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318, 206319, 206320, 206321, 206322, 206323, 206324, 206326, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349, 206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359, 206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369, 206370, 206372, 206373, 206374, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206408, 206409, 206410, 206411, 206412, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435, 206436, 206438, 206439, 206441, 206442, 206443, 206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453, 206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463, 206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473, 206474, 206475, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206487, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206495, 206496, 206497, 206498, 206499, 206500, 206501, 206503, 206504, 206505, 206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515, 206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525, 206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535, 206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545, 206546, 206547, 206548, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206559, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206568, 206569, 206570, 206571, 206572, 206573, 206574, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206597, 206598, 206599, 206600, 206601, 206602, 206603, 206604, 206605, 206606, 206607, 206608, 206609, 206610, 206611, 206612, 206613, 206614, 206615, 206616, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206640, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206702, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711.
RECALLING FIRM/MANUFACTURER
MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by letters dated April 28, 2005. Firm initiated recall is ongoing.
REASON
The Welch Allyn AED 20 product may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.
VOLUME OF PRODUCT IN COMMERCE
597 units.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Label reads: Manufacturer: Medtronic, Inc. Minneapolis, MN. Recall # Z-0808-05.
CODE
Catalog/custom Pack Number 0A39R17 with Lot no.'s 0411002937 and 0412002577 Catalog/Customer Pack Number 0A52R12 with Lot no. 0411005077; Catalog/Customer Pack Number 0E35R1 with Lot no. 0501004491; Catalog/Customer Pack Number 0M97R17 with Lot no. 0411005084; Catalog/Customer Pack Number 0M97R18 with Lot no. 0501002954; Catalog/Customer Pack Number 0M98R18 with Lot no. 0411003731; Catalog/Customer Pack Number 0M99R17 with Lot no. 0411003732; Catalog/Customer Pack Number 0N41R7 with Lot no.'s 0411000788, 0411006283, 0412002182 and 0501001313; Catalog/Customer Pack Number 0N70R14 with Lot no.'s 0411003196 and 0411003196; Catalog/Customer Pack Number 0R26R1 with Lot no. 0410004599; Catalog/Customer Pack Number 0Y50R8 with Lot no. 0501001053; Catalog/Customer Pack Number 0Z30R6 with Lot no. 0411000770; Catalog/Customer Pack Number 0Z99R1 with Lot no. 0502003204; Catalog/Customer Pack Number 1845R29 with Lot no. 0412005193; Catalog/Customer Pack Number 1A46R5 with Lot no. 0501003689; Catalog/Customer Pack Number 1A63R6 with Lot no. 0412002081; Catalog/Customer Pack Number 1B23R2 with Lot no. 0412001125; Catalog/Customer Pack Number 1B23R4 with Lot no. 0502002363; Catalog/Customer Pack Number 1B31R2 with Lot no.'s 0411002428, 0411003734, 0411006211, 0501001326, 0501002968 and 0501004492; Catalog/Customer Pack Number 1B37R4 with Lot no. 0501001675; Catalog/Customer Pack Number 1C33R1 with Lot no. 0411003738; Catalog/Customer Pack Number 1C44R4 with Lot no.'s 0410005787, 0412000449 and 0501004469; Catalog/Customer Pack Number 1C87R3 with Lot no. 0411005042; Catalog/Customer Pack Number 1D80R7 with Lot no. 0411003404; Catalog/Customer Pack Number 1D80R8 with Lot no. 0502000042; Catalog/Customer Pack Number 1E87R1 with Lot no. 0411002441; Catalog/Customer Pack Number 1E87R2 with Lot no. 04120030957; Catalog/Customer Pack Number 1E99R4 with Lot no. 0501002058; Catalog/Customer Pack Number 1F03R1 with Lot no. 0412000472; Catalog/Customer Pack Number 1F04R2 with Lot no's. 0412003489 and 0501002849; Catalog/Customer Pack Number 1G06R11 with Lot no. 0412001595; Catalog/Customer Pack Number 1G37R3 with Lot no. 0411003209; Catalog/Customer Pack Number 1G69R7 with Lot no. 0412002553; Catalog/Customer Pack Number 1G75R1 with Lot no. 0412003470; Catalog/Customer Pack Number 1H24R6 with Lot no. 0412001207; Catalog/Customer Pack Number 1H50R5 with Lot no. 0411003411; Catalog/Customer Pack Number 1J01R with Lot no. 0501002510; Catalog/Customer Pack Number 1J29R1 with Lot no. 0501002848; Catalog/Customer Pack Number 1K09R3 with Lot no. 0412002172; Catalog/Customer Pack Number 1K72R4 with Lot no. 0502000853; Catalog/Customer Pack Number 1L77R7 with Lot no. 0411006056; Catalog/Customer Pack Number 1M68R2 with Lot no. 0412002559; Catalog/Customer Pack Number 1N25R5 with Lot no. 0502003198; Catalog/Customer Pack Number 1N77R6 with Lot no. 0501002933; Catalog/Customer Pack Number 1N93R1 with Lot no. 0502002615; Catalog/Customer Pack Number 1Q10R4 with Lot no. 0411006908; Catalog/Customer Pack Number 1Q28R1 with Lot no. 0412000476; Catalog/Customer Pack Number 1R13R2 with Lot no. 0411002155; Catalog/Customer Pack Number 1R14R2 with Lot no. 0501005938; Catalog/Customer Pack Number 1U84R3 with Lot no. 0411006923; Catalog/Customer Pack Number 2162R3 with Lot no.'s 0411005070 and 0412005207; Catalog/Customer Pack Number 2380R7 with Lot no. 0411006916; Catalog/Customer Pack Number 2567R34 with Lot no.'s 0412000978 and 0501003678; Catalog/Customer Pack Number 2841R32 with Lot no. 0411000393; Catalog/Customer Pack Number 2A96R with Lot no. 0411003443; Catalog/Customer Pack Number 2C88R2 with Lot no. 0412001122; Catalog/Customer Pack Number 2D86R8 with Lot no. 0411006913; Catalog/Customer Pack Number 2D93R6 with Lot no. 0411003730; Catalog/Customer Pack Number 2E74R9 with Lot no. 0411004495; Catalog/Customer Pack Number 2L74R4 with Lot no. 0411002893; Catalog/Customer Pack Number 2P77R3 with Lot no. 0411002443; Catalog/Customer Pack Number 2R17R1 with Lot no. 0412004981; Catalog/Customer Pack Number 2V38R2 with Lot no. 0411006212; Catalog/Customer Pack Number 2W79R1 with Lot no. 0411002930; Catalog/Customer Pack Number 2W98R6 with Lot no. 0412002558; Catalog/Customer Pack Number 2Y74R2 with Lot no. 0501000436; Catalog/Customer Pack Number 2Y78R5 with Lot no.'s 0412001590 and 0501002781; Catalog/Customer Pack Number 3D21R1 with Lot no. 0411006924; Catalog/Customer Pack Number 3F11R2 with Lot no. 0412005199; Catalog/Customer Pack Number 3F83R1 with Lot no.'s 0412002171, 0412003472 and 0412004460; Catalog/Customer Pack Number 3L07R2 with Lot no. 0501004498; Catalog/Customer Pack Number 3Q80R3 with Lot no. 0412003468; Catalog/Customer Pack Number 3R14R4 with Lot no. 0502001780; Catalog/Customer Pack Number 3S01R4 with Lot no. 0502002361; Catalog/Customer Pack Number 3S79R2 with Lot no. 0411006608; Catalog/Customer Pack Number 3V39R with Lot no. 0411006910; Catalog/Customer Pack Number 4B19R3 with Lot no. 0502001785; Catalog/Customer Pack Number 4B82R with Lot no. 0501005425; Catalog/Customer Pack Number 9015R8 with Lot no. 0411003414; Catalog/Customer Pack Number 9063R9 with Lot no. 0501002505; Catalog/Customer Pack Number 9251R16 with Lot no.''s 0411003749 and 0412004062; Catalog/Customer Pack Number CB0M50R2 with Lot no.'s 0411006331 0412000701 and 0412003740; Catalog/Customer Pack Number CB0R21R2 with Lot no. 0411005057; Catalog/Customer Pack Number CB0S15R7 with Lot no.'s 0411004246, 0412003181 and 0501004470; Catalog/Customer Pack Number CB1C78R11 with Lot no.'s 0411005055 and 0412001564; Catalog/Customer Pack Number CB2690-1 with Lot no. 0411002434; Catalog/Customer Pack Number CB2C36R10 with Lot no. 0412001209; Catalog/Customer Pack Number CB2E68R3 with Lot no.'S 0411006933 and 0412005212; Catalog/Customer Pack Number CB2H63R5 with Lot no. 0412003184; Catalog/Customer Pack Number CB2K05R4 with Lot no.'S 0411003199 and 0412001229; Catalog/Customer Pack Number CB2Z67R2 with Lot no. 0412005211; Catalog/Customer Pack Number CB3L15R3 with Lot no. 0411005056; Catalog/Customer Pack Number CB3Q10R1 with Lot no. 0501004457; Catalog/Customer Pack Number CB3T25R2 with Lot no. 0501005426; Catalog/Customer Pack Number CB3U51R2 with Lot no. 0411006084; Catalog/Customer Pack Number CB3U51R5 with Lot no.'s 0501000085 and 0501000443; Catalog/Customer Pack Number CB3W16R3 with Lot no. 0502001415; Catalog/Customer Pack Number CB3Z05R with Lot no.'s 0411006935 and 0502002616; Catalog/Customer Pack Number CB4B28R with Lot no. 0501002773; Catalog/Customer Pack Number HY2J04R2 with Lot no. 0412000923; Catalog/Customer Pack Number HY2U30R3 with Lot no. 0411001294 and 0501001294; Catalog/Customer Pack Number HY3E77R6 with Lot no.'s 0410008224, 0412001560 and 0501002937; Catalog/Customer Pack Number HY3Y36R with Lot no. 0501003677; Catalog/Customer Pack Number TL2K47R3 with Lot no.'s 0411003194 and 0412003178; Catalog/Customer Pack Number TL2M65R1 with Lot no. 0410003692; Catalog/Customer Pack Number TL2P93R1 with Lot no.'s 412001991, 0501002979 and 0502002686; Catalog/Customer Pack Number TL2P94R6 with Lot no. 0412000922; Catalog/Customer Pack Number TL2Q00R6 with Lot no. 0411003751; Catalog/Customer Pack Number TL2Q02R6 with Lot no. 0412002584; Catalog/Customer Pack Number TL2S57R3 with Lot no. 0411006070; Catalog/Customer Pack Number TL3B47R8 with Lot no.'s 0411004731 and 0412005219; Catalog/Customer Pack Number TL3C36R1 with Lot no. 0501001293; Catalog/Customer Pack Number TL3C66R4 with Lot no. 0412003164; Catalog/Customer Pack Number TL3F46R1 with Lot no. 0502000857; Catalog/Customer Pack Number TL3G03R1 with Lot no. 0411004739; Catalog/Customer Pack Number TL3G34R with Lot no.'s 0411004988 and 0411006937; Catalog/Customer Pack Number TL3H76R7 with Lot no.'s 0411004741 and 0501001692; Catalog/Customer Pack Number TL3P08R with Lot no.'s 0411003748 and 0412005195; Catalog/Customer Pack Number TL3R32R with Lot no. 0411006939; Catalog/Customer Pack Number TL3R59R4 with Lot no. 0411003763; Catalog/Customer Pack Number TL3Z67R2 with Lot no.'s 0412004544 and 0501000804; and Catalog/Customer Pack Number TL4A82R with Lot no. 0411006604. TOTAL SYSTEMS: Total System TS8184R9 with Lot no.'s 11323584, 11281448, 11262323, 11229369 and 11189019; Total System TS8161R6 with Lot no.'s 11301690, 11271898, 11190528 and 11376510; Total System TS8163R7 with Lot no.'s 11294151, 11278357, 11249648, 11235370, 11209905, 11172365, 11159434, 11127913 and 11092587 ; Total System TS9632R32 with Lot no.'s 11314733, 11264825 and 11199673; Total System TS9422R30 with lot no.'s 11085227, 11101188, 11022556, 11369433, 11208288 and 11151238A; Total System TS1265R6 with Lot no.'s 11344914, 11341867, 11216620 and 11213665; Total System TS1231R10 with Lot no.'s 11276692, 11036456 and 11007721; Total System TS8240R3 with Lot no.'s 11348660 and 11271850; Total System TS8258R1 with Lot no.'s 11361686 and 11343264; Total System TS8151R7 with Lot no.'s 11281057, 11259915, 11245459, 11236224, 11209834 and 11196880; Total System TS8009R7 with Lot no.'s 11432303, 11389716B, 11365733, 11365733B, 11353727, 11297859, 11277544A, 11388228, 11389716B, 11384983A, 11365733B and 11374909; Total System TS8101R5 with Lot no.'s 11355174, 11326135, 11280917, 11261447, 11246651, 11233518, 11219744, 11187093, 11154628, 11148913, 11146030 and 11025969; Total System TS8387R with lot no. 10935463; Total System TS 8363R with lot no.'s 11232452, 11209241, 11170011, 11134085, 11044590, 11280218, 11355877A, 11319313, 11362213, 11335475, 11322560, 11277524 and 11221479; Total System TS8275R2 with Lot No.'s 11143684, 11117484, 11113585 and 11078654; Total System TS8287R with Lot no. 11304060; Total System TS8299R with Lot no.'s 11237797 and 11207329; Total System TS8385R with lot no.'s 10890724 and 11157079A; Total System TS8329R3 With Lot no.'s 11319074, 11282455, 11269241, 11260213, 11237174, 11211041, 11355036 and 11326059; Total System TS8339R1 with Lot no.'s 11240930, 1161677 and 11364737; Total System TS8394R1 with Lot no. 11275457; Total System TS8329R3 with Lot no.'s 11454233, 11435228, 11404947 and 11392251; Total System TS8390R with Lot no. 11019052; and Total System TS 8367R1 with Lot no.'s 11247834, 11107184, 11063353, 11033869, 11355872, 11278049 and 11144479.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters beginning March 25, 2005.
Manufacturer: Medtronic Mexico, S. De R.L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly and had been sterilized, the ruptured seal breaches the sterility barrier for the package.
VOLUME OF PRODUCT IN COMMERCE
4,131 devices (3,373 within US).
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Nichols IRMA Intact PTH Assay, catalog No. 40-2171. Recall # Z-0809-05.
CODE
Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005.
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clemente, CA, by letters on March 9 and ll, 2005. Firm initiated recall is ongoing.
REASON
Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
VOLUME OF PRODUCT IN COMMERCE
Not divulged.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040. Recall # Z-0810-05.
CODE
Lots 62-402598 and 62-402622.
RECALLING FIRM
Nichols Institute Diagnostics, San Clemente, CA, by letters dated March 25, 2005. Firm initiated recall is ongoing.
REASON
Values do not agree with Directional Instructions (DI). Lot 62-402598's results were outside the DI claim for functional sensitivity, reproducibility, parallelism and two interfering substances. Lot 62-402622's results were outside the DI claim for functional sensitivity, reproducibility, recovery, parallelism and two interfering substances.
VOLUME OF PRODUCT IN COMMERCE
13,751.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Product Code EC1001. Recall # Z-0811-05.
CODE
Lot Number, exp. date: MS020434, EXP APRIL-2005; MS0504003, EXP APRIL-2005; MS0504027, EXP MAY-2005; MS0604006, EXP MAY-2005; MS0604007, EXP MAY-2005; MS0704006, EXP JUNE-2005; MS0704015, EXP JUNE-2005; MS0804007, EXP AUGUST-2005; MS1004007, EXP OCTOBER-2005; MS1104021, EXP OCTOBER-2005; MS0105002, EXP JANUARY-2006; MS0105047, EXP FEBRUARY-2006; MS0205039, EXP FEBRUARY-2006; MS0205036, EXP MARCH-2006; MS0205041, EXP MARCH-2006; MS0205042, EXP MARCH-2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartport, Inc., Somerville, NJ, by telephone on April 8, 2005.
Manufacturer: MedSource Technologies-Laconia, Laconia, NH. Firm initiated recall is ongoing.
REASON
Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
1,029 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) ENTrak Navigation and Visualization System.
Recall # Z-0812-05;
b) ENTrak Plus Navigation and Visualization System.
Recall # Z-0813-05;
c) InstaTrak 3500 Navigation and Visualization System.
Recall # Z-0814-05;
d) InstaTrak 3500 Plus Navigation and Visualization System.
Recall # Z-0815-05;
CODE
Axcess System Kit P/N: 1005869-001.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on July 12, 2004. Firm initiated recall is ongoing.
REASON
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
VOLUME OF PRODUCT IN COMMERCE
15 KITS.
DISTRIBUTION
VA, CT, KY, NJ, LA,PA, TN, OK, CA, and Germany.

_______________________________
PRODUCT
Tube Stand for the Dynarad Phantom Mobile X-Ray System. Catalog #501031. Recall # Z-0816-05.
CODE
All Phantom Model Tube Stands with squared corners on all four corners of the stand. Serial numbers 00743-0204, 00778-0204, 00997-0304, 01001-0304, 01103-0304, 01293-0304, 01371-0304, 01425-0404, 01452-0404, 01470-0404, 01475-0404, 01575-0404, 01592-0404, 01700-0404, 01704-0404, 01790-0404, 01841-0404, 01851-0404, 01898-0504, 02019-0504, 02023-0504, 02051-0504, 02096-0504, 02178-0504, 02188-0504, 02310-0604, 02357-0604, 02429-0604, 02517-0604, 02534-0604, 02584-0604, 02671-0604, 02752-0704, 02760-0704, 02776-0704, 02839-0704, 02891-0704, 02928-0704, 02938-0704, 02945-0704, 02959-0704, 02980-0704, 02991-0704, 03076-0704, 03084-0704, 03122-0704, 03375-0804, 03455-0804, 03476-0804, 03518-0804, 03534-0804, 03570-0904, 03579-0904, 03636-0904, 03700-0904, 03708-0904, 03722-0904, 03740-0904, 03952-0904, 04037-0904, 04134-1004, 04183-1004, 04347-1004, 04380-1004, 04407-1004, 04477-1004, 04481-1004, 04491-1004, 04524-1004, 04534-1004, 04592-1104, 04600-1104, 04605-1104, 04648-1104, 04694-1104, 04699-1104, 04703-1104, 0439-1104, 04783-1104, 04862-1104, 05190-1204, 05194-1204, 05198-1204, 05216-1204, 05364-1204, 05414-1204, 05418-1204, 05439-1204, 00283-0105, 00340-0105, 00481-0105, 00571-0205, 00575-0205, 00617-0205, 00649-0205, 00763-0205, 00841-0205, 00858-0205, 00891-0205, 00900-0205, 00913-0205.
RECALLING FIRM/MANUFACTURER
Del Medical Systems Group, Franklin Park, IL, by letters dated March 10, 2005. Firm initiated recall is ongoing.
REASON
The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
VOLUME OF PRODUCT IN COMMERCE
31 tubestands.
DISTRIBUTION
Nationwide, Mexico and Thailand.

_______________________________
PRODUCT
KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak Direct View CR 500 systems. Screens are sold in the following sizes and Cat. No's: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm. Recall # Z-0817-05.
CODE
Each screen has a 17-digit code. Product subject to recall includes ALL codes containing "CE" and "CR" and codes with "CO" with date code of "051" or lower. NOTE: The date codes are the 8th thru 10th digit and equal the julian date. The YEAR CODES are the 11th and 12th digit. The codes are located at the top edge of the CR screen. i.e. xxxxxxx051CO#xxxx.
FIRM/MANUFACTURER
Eastman Kodak Co., Rochester, NY, by letters on April 8, 2005. Firm initiated recall is ongoing.
REASON
Screens may be affected with image artifacts.
VOLUME OF PRODUCT IN COMMERCE
6,900 screens.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Axiom Artis MP X-Ray System. Recall # Z-0818-05.
CODE
Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.
RECALLING FIRM
Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on April 1, 2005. Firm initiated recall is ongoing.
REASON
Potential problem with the fluoroscopy switch on the power grip.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ECAT PET Scanners (mobile systems), Reveal XL (mobile systems), and Sceptre and Sceptre XL (mobile systems). Recall # Z-0819-05.
CODE
Model Number: 3600079-00 Serial numbers: 0001013, 0001014 Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054 Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063 Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082, Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110 Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018 Model Number: 3600085-00 Serial numbers: 0001001, 0001002 Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062 Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060 Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108 Model Number: 3600099-00 Serial numbers: 0301024 Model Number: 3600088-00 Serial numbers: 001058 Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061.
FIRM/MANUFACTURER
CTI PET Systems Inc., Knoxville, TN, by letters beginning April 5, 2005. Firm initiated recall is ongoing.
REASON
Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
VOLUME OF PRODUCT IN COMMERCE
80 units.
DISTRIBUTION
Nationwide, Canada, the Netherlands, Ireland and Denmark.

_______________________________
PRODUCT
Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, Contents: 3 fibre-tipped swabsticks premoistened with Moi-Stir mouth moistening solution and saliva supplement; Product No's. 55299-703-03 and 55299-703-25. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 fail packs to the case. Recall # Z-0820-05.
CODE
Lots A2, 1193, 1209, 1233, 1260 and 1725.
RECALLING FIRM/MANUFACTURER
Kingswood Laboratories, Inc., Indianapolis, IN, by press release and letter dated April 22, 2005. Firm initiated recall is ongoing.
REASON
Contaminated with Aspergillus and Penicillum molds.
VOLUME OF PRODUCT IN COMMERCE
302,600 swabs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly
(989600087501); replacement x-ray tube housing
assemblies; Model DA 200 and MX200, Part number
875-01; Recall # Z-0838-05;
b) Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube
Housing Assembly (989600088401); replacement x-ray tube
housing assemblies; Model DA 200 PRO and MX200 PRO,
part number 875-01. Recall # Z-0839-05;
c) Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube
Housing Assembly (989600088701); replacement x-ray
tube housing assemblies; Model DA 200 Ultra and MX200
Ultra, Part number 875-01. Recall # Z-0840-05.
CODE
a) Serial (anode) numbers 13426, 13428, 13437, 13449,
15714, 16539, 16941, 16942, 16951, 16962, 16963,
17536, 17539, 17541, 17543, 17547, 18727, 18728,
18729, 18731, 18732, 18733, 18736, 18743, 18745,
18747, 18749, 18753, 18755, 18999, 20206, 20208,
20211, 20216, 20219, 20220, 20222, 20225, 21800,
21803, 21806, 21809, 21810, 21816, 21818, 21819,
21820, 21823, 21824, 21825, 21827, 21829, 21843,
21849, 21853, 23113, 23122, 23132, 23140, 23143,
23144, 23516, 23518, 23522, 23524, 23532, 23534,
23554, 23888;
b) Serial (anode) numbers 17549, 18997, 21821, 23112;
c) Serial (anode) numbers 18986, 18987, 18988, 18996,
19000, 19004, 21799, 21801, 21841, 21844, 23107,
23116, 23117, 23121, 23124, 23125, 23126, 23137,
23139, 23525, 23529, 23536, 23537, 23538, 23541,
23542, 23544, 23545, 23548, 23550, 23552, 23883,
23884, 23894, 23895, 23906, 23908.
RECALLING FIRM/MANUFACTURER
Dunlee, Aurora, IL, by letters dated April 4, 2005. Firm initiated recall is ongoing.
REASON
The X-ray tube housing assembly may have been mounted with the incorrect sized bolts.
VOLUME OF PRODUCT IN COMMERCE
110 units.
DISTRIBUTION
Nationwide and Taiwan, Germany and Mexico.

_______________________________
PRODUCT
Continuum MR Compatible Infusion Pump. Pump Model #3009135. Recall # Z-0841-05.
CODE
Serial numbers 1000 through 300017.
RECALLING FIRM/MANUFACTURER
Medrad, Inc., Indianola, PA, by letter dated March 9, 2005. Firm initiated recall is ongoing.
REASON
Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.
VOLUME OF PRODUCT IN COMMERCE
461 units.
DISTRIBUTION
CA, DC, MD, NJ, SC, WA, WV, and Internationally.

_______________________________
PRODUCT
The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit. Recall # Z-0842-05.
CODE
All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter beginning on March 23, 2005. Firm initiated recall is ongoing.
REASON
The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.
VOLUME OF PRODUCT IN COMMERCE
2,418 units.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________
PRODUCT
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.
CODE
All versions of software.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, on September 24, 2004.
Manufacturer: Polymedco, Inc., Cortlandt Manor, NY. Firm initiated recall is ongoing.
REASON
A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the "refresh button" has not been pressed. The graph may appear valid; however erroneous results may occur.
VOLUME OF PRODUCT IN COMMERCE
68 (27-2.7; 14-2.8 and 27-2.8.1 Software Version).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 920654225.
Recall # Z-0824-05;
b) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S
or model 9212A), catalog no. 920654335.
Recall # Z-0825-05;
c) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925474325.
Recall # Z-0826-05;
d) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925554325.
Recall # Z-0827-05;
e) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925574325.
Recall # Z-0828-05;
f) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925654220.
Recall # Z-0829-05;
g) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925654325.
Recall # Z-0830-05;
h) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925674320.
Recall # Z-0831-05;
i) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925674335.
Recall # Z-0832-05;
j) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925754335.
Recall # Z-0833-05;
k) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 925774325.
Recall # Z-0834-05;
l) Advisor Vital Signs Monitor (model 9200) with
Capnography options installed (model 9212S or
model 9212A), catalog no. 92E654325.
Recall # Z-0835-05.
CODE
a) Serial no. 706692007;
b) Serial no. 706741003;
c) Serial no. 706573001, 706573002, 706590000 and
706590001;
d) Serial no. 706710004, 706710005, 706710006,
706710007, 706710008 and 706710009;
e) Serial no. 706503016, 706503017, 706503018,
706503019, 706503020, 706503021, 706503022,
706503023, 706503024, 706503025, 706640011,
706640012, 706640013, 706640014, 706640015,
706640016, 706640017, 706640018, 706640019,
706640020, 706640021, 706640022, 706640023,
706640024, 706640025, 706640026, 706640027,
706640028, 706640029 and 706740000;
f) Serial no. 706522000, 706522001, 706522002,
706522003, 706522004, 706522005, 706522006,
706522007, 706522008, 706522009, 706522013,
706522024, 706522026, 706522027 and 706522028;
g) Serial no. 706330001, 706330002, 706330003,
706330004, 706330005 and 706431007;
h) Serial no. 706607001;
i) Serial no. 706684000 and 706884001;
j) Serial no. 706331000, 706331001, 706331002,
706331003, 706331004, 706331005, 706331006,
706331007, 706331008, 706331009, 706331010,
706331011, 706331012, 706331013 and 706331014;
k) Serial no. 706580000, 706580002, 706580003,
706580004, 706592000, 706592007, 706592010
and 706640010;
l) Serial no. 706460000, 706460001, 706601000,
706601001, 706601002, 706601003, 706601004,
706601005, 706601006, 706601007, 706601008,
706601009 and 706601010.
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc, Waukesha, WI, by e-mail on March 16, 2005. Firm initiated recall is ongoing.
REASON
Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
VOLUME OF PRODUCT IN COMMERCE
102 monitors (2 domestic and 100 international).
DISTRIBUTION
CA, NY and Internationally.

_______________________________
PRODUCT
a) Centurion brand CirClamp with 1.3 cm bell, sterile,
single use: product 330. Recall # Z-0836-05;
b) Centurion brand CirClamp with1.1 cm bell, sterile,
single use; product 310. Recall # Z-0837-05.
CODE
a) Lots 11224 and 06284;
b) Lot 11224.
RECALLING FIRM/MANUFACTURER
Tri-State Hospital Supply Corp, Howell, MI, by letter dated April 12, 2005. Firm initiated recall is ongoing.
REASON
Lot 11224 of product 330 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
VOLUME OF PRODUCT IN COMMERCE
5,650.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR May 18, 2005

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