• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for May 25, 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 25, 2005
05-21

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS I

______________________________

PRODUCT
Design a Face Make-up. Various configurations that include: Theme Packs; Color Compacts, 6 Color Paint Packs; Body Glitter Gel, Glow in the Dark Paint, Face Paint Stencil, Face Paint Foam Stampers, and Face Paints with Book. Recall # F-384-5.
CODE
Item Numbers: (No lots identified) 8900 --Theme Pack - Sports; 8901--Theme Pack - Puppies; 8902--Theme Pack - Kittens; 8903-- Theme Pack - Tiger; 8904--Theme Pack - Clown; 8905 -- Color Compact - White -Clamshell; 8906-- Color Compact - Black -Clamshell; 8907-- Color Compact - Sky Blue -Clamshell; 8908 --Color Compact - Red -Clamshell; 8909 --Color Compact - Green --Clamshell; 8910 --Color Compact - Pink --Clamshell; 8911 --Color Compact - Yellow - Clamshell; 8912 --Color Compact - Orange - Clamshell; 8913 --Color Compact - Brown - Clamshell; 8914 --Color Compact - Purple - Clamshell; 8915 --Color Compact - Navy Blue - Clamshell; 8916 --6 Colors Paint Pack; 8919 --Face Paint Studio - Med. Box; 8920 --Body Glitter Gel; 8921 -- Glow in the Dark Paint; 8922 -- Face Paint Stencil; 8923 --Face Paint Foam Stampers; 8927--Face Paints with Book.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rose Art Industries, Inc., Livingston, NJ, by letter on March 18, 2005.
Manufacturer: Galisa Cosmetics International Corp., Hsintien Taipei Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
Face paint products have caused minor adverse reactions in children. Adverse reactions include redness of the skin or a skin rash, irritation, itching or minor swelling in the area where the paints were applied.
VOLUME OF PRODUCT IN COMMERCE
1,629,444 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Russell Hobbs Mona Cordless Jug Kettle; a cordless electric kettle about 10 inches high, silver brushed matte finish stainless steel body with a black handle and base, with "Russell Hobbs" imprinted on the lower side of the kettle; 1 liter/32 fl. oz. capacity. Recall # F-292-5.
CODE
Model RHMK 3022, all units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Salton Inc, Lake Forest, IL, by e-mail on October 29, 2004, by telephone on November 2, 2004, by letter on November 3, 2004, and by press release on February 18, 2005.
Manufacturer: Chiaphua Industries Limited, Shenzen, China. Firm initiated recall is ongoing.
REASON
The kettle leaches lead into food prepared in the kettle. This can result in the food containing lead levels high enough to cause irreversible health consequences or death.
VOLUME OF PRODUCT IN COMMERCE
7,732 kettles.
DISTRIBUTION
Nationwide and Canada, Trinidad & Tobago.

 

_______________________________
PRODUCT
Best Brands Custom Sugar Pre-Cut Frozen Cookie Dough, sold in 3 different puck sizes: 1.25 oz, 1.5 oz and 2.0 oz. Product code 1043-02 for 1.25 oz pucks. Product code 1043-01 for 1.5 oz pucks. Product code 1043-05 for 2.0 oz pucks. Frozen sugar cookie dough pucks are distributed in poly-lined cardboard cases. Recall # F-362-5.
CODE
All date/lot codes are being recalled.
RECALLING FIRM/MANUFACTURER
Best Brands, Corp., Eagan, MN, by press release, telephone or fax and by letter beginning March 23, 2005. Firm initiated recall is ongoing.
REASON
Frozen Sugar Cookie dough contains undeclared dried whole eggs. Cookie dough is sold to retail and grocery store bakeries and foodservice outlets. Consumers would have purchased the product as baked cookies of various shapes and sizes, either decorated or plain.
VOLUME OF PRODUCT IN COMMERCE
9,900 cases.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Five Star Chocolate Bar Fruit & Nut **Pralines, Pecans, Cherries and Dark Chocolate, 2 ounces, UPC:769933005024. Recall # F-363-5.
CODE
Lot Number: 05056.
RECALLING FIRM/MANUFACTURER
Champlain Chocolate, Inc., Burlington, VT, by telephone on March 29, 2005 and by letter dated April 1, 2005. Firm initiated recall is ongoing.
REASON
Packages labeled as Fruit & Nut Chocolate Bars actually contained Peanut Chocolate Bars with peanuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
3,344 bars.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) Baklava Fingers further labeled as "Homemade hand-rolled
fillo dough rolled around grounded cashews and pine nuts",
Half and Full Sheet sized boxes, Recall # F-364-5;
b) Kol Shkor further labeled as "Fourteen sheets of
homemade hand-rolled fillo endowed with cashews and
pine nuts", Half and Full Sheet sized boxes,
Recall # F-365-5;
c) Baklava Pistachios further labeled as "Thirty two sheets
of homemade hand-rolled fillo stuffed with pistachios",
Half and Full Sheet sized boxes. Recall # F-366-5;
d) Baklava Walnuts further labeled as "Sixteen sheets of
homemade hand-rolled fillo stuffed with walnuts",
Half and Full Sheet sized boxes. Recall # F367-5;
e) Basma Cashews further labeled as "Grinded kanafe dough
evenly spread by cashews and pine nuts into two
separate layers", Half and Full Sheet sized boxes.
Recall # F-368-5;
f) Basma Pistachios further labeled as "Grinded kanafe
dough evenly spread by pistachios into two separate
layers", Half and Full Sheet sized boxes.
Recall # F-369-5;
g) Mamoul Mad Pistachios further labeled as "Mamoul dough
spread into two separate layers, separated by pistachios",
Half and Full Sheet sized boxes. Recall # F-370-5;
h) Mamoul Mad Dates further labeled as "Mamoul dough
spread into two separate layers, separated by dates",
Half and Full Sheet sized boxes. Recall # F-371-5;
i) Petit Fours Butter Cookies, Half and Full Sheet
sized boxes. Recall # F-373-5;
j) Eye of Gazal further labeled as "was invented by the
founder of AlGondoline. A light tasty butter cookie
that is perfect for all occasions.", Half and Full
Sheet sized boxes. Recall # F-374-5;
k) Ghraybeth further labeled as "Shredded wheat rounded
baked with pistachios on top", Half and Full Sheet
sized boxes. Recall # F-375-5;
l) Nammoura further labeled as "A delicate blend of
semolina and farina baked to golden brown, then
topped with our homemade syrup and almond",
Half and Full Sheet sized boxes. Recall # F-376-5;
m) Barazik further labeled as "A delightful cookie
coated with sesame on the top and pistachios on the
bottom", Half and Full Sheet sized boxes.
Recall # F-377-5;
n) Assorted Sweet Tray further labeled as "Baklava,
Baklava Fingers, Kol-shkor, Baklava Pyramids,
Burma Pistachios, Burma Cashews/pine nuts,
Ballourieh, Basma Pistachios, and Basma Cashews",
Half and Full Sheet sized boxes. Recall # F-381-5.
CODE
Firm does not use lot coding. Recall includes all product within expiry life.
RECALLING FIRM/MANUFACTURER
ZNH Corp., Richardson, TX, by press release on February 25, 2005, and by letters on February 28, 2005. Firm initiated recall is ongoing.
REASON
a), b), c), d), e), f), h), m), and n) Product
contains undeclared Allergens: butter and wheat;
g) Product contains undeclared Allergens and Colors:
butter, wheat, colors Yellow #5 and Yellow #6;
i) and j) Product contains undeclared Allergens:
wheat and eggs.
k) Product contains undeclared Allergens: butter;
l) Product contains undeclared Allergens: yogurt.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,265 pounds of pastries (total).
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) SeaSpecialties MAMA's premium quality Nova
Smoked Salmon, full 1/4 LB, Net 4OZ (113GRAMS).
Recall # F-382-5;
b) SeaSpecialties MAMA's premium quality Nova
Smoked Salmon, snacks, packed in 8 OZ. vacuum.
Recall # F-383-5.
CODE
a) and b) Sell by AUG 10 2005, lot #31782.
RECALLING FIRM/MANUFACTURER
Sea Specialties, Miami, FL, by fax and telephone beginning on March 18, 2005. Firm initiated recall is ongoing.
REASON
Laboratory analysis performed by the State of Florida showed that the product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
287 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

______________________________
PRODUCT
a) Mamoul Pistachios further labeled as "A traditional
holiday cookie of the middle east. A delicate blend
of samolina, flour, pure butter filled with
pistachios, and covered with powdered sugar.",
Half and Full Sheet sized boxes. Recall # F-372-5;
b) Ballourieh further labeled as "Shredded fillo dough
filled with chopped pistachios, lightly baked, and
flavored with a hint of orange blossom",
Half and Full Sheet sized boxes. Recall # F-378-5;
c) Burma Pistachios further labeled as "Homemade shredded
fillo dough rolled around grounded pistachios",
Half and Full Sheet sized boxes. Recall # F-379-5;
d) Mini Mamoul Pistachios further labeled as "A traditional
holiday cookie of the middle east. A delicate blend of
samolina, flour, pure butter filled with pistachios,
and covered with powdered sugar.", Half and Full
Sheet sized boxes. Recall # F-380-5.
CODE
Firm does not use lot coding. Recall includes all products within expiry life.
RECALLING FIRM/MANUFACTURER
ZNH Corp., Richardson, TX, by press release on February 25, 2005, and by letters on February 28, 2005. Firm initiated recall is ongoing.
REASON
a) Product contains undeclared Colors: FDC Yellow #5
and Yellow #6;
b), and c) Product contains undeclared Allergen: wheat;
d) Product contains undeclared Colors: FDC Yellow #5
and Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,265 pounds of pastries (total).
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

______________________________

PRODUCT
Actra-Rx Gentlemen Nutritional Supplement Capsules, Proprietary Blend: Amino acid blend (Proline, Histidine, Glutamic Acid, Argenine, Aspartic Acid, Tyrosine, Phenylalanine, Lysine, Leucine, Glycosine, Threonine, iso-Leucine, Alanine, Senine, Methionine, Trytophane and Cystis Acid) Lycium (Fruit), Epimedium (Herb) Cistanche (Root) Vitamins B1, B2 and Minerals, 450mg, 5 count bottles, No Preservatives Added. Recall # D-234-5.
CODE
Lot 001-3, Exp date December 2005.
RECALLING FIRM
Recalling Firm: Body Basics Inc,. Canoga Park, CA, by FDA issued press release on Nov. 2, 2004. Manufacturer: Shenyang Chang Gang Yibao Alcohol Co., Ltd, Shenyang, Liaoning, Mainland China. Firm initiated recall is complete.
REASON
Unapproved New Drug; contains undeclared sildenafil citrate.
VOLUME OF PRODUCT IN COMMERCE
15,000 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

*****CORRECTION*****

In the May 11, 2005 Enforcement Report 05-19,
Recall # D-198-5, Forest Armour Thyroid 1 grain tablets packaged in 50,000-tablet drums. Lot number 090308, Exp. Aug-05 should be added.

Recall # D-217-5, Armour Thyroid (thyroid tablets, USP), 30 mg., Recall # D-218-5, Armour Thyroid (thyroid tablets, USP), 60 mg., and Recall # D-219-5, Armour Thyroid (thyroid tablets, USP), 120 mg., the classification has been changed from a Class II to Class III recall.

_______________________________

PRODUCT
Butorphanol Tartrate Nasal Spray, 10 mg/mL, 2.5 mL bottle with Metered-dose Spray Pump, packaged in boxes of 48 bottles, Rx only, **** NDC 0378-9639-43. Recall # D-228-5.
CODE
LAL041 Exp 6/05 LAL042 Exp 7/05 LAL045 Exp 11/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mylan Pharmaceuticals Inc., Morgantown, WV, by letter on March 22, 2005.
Manufactured by Patheon, Inc. Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Short fill; could result in higher concentration of active ingredient.
VOLUME OF PRODUCT IN COMMERCE
91,570 bottles.
DISTRIBUTION
Nationwide.

______________________________

PRODUCT
Famotidine Injection, 20mg/2mL*, Each mL contains 10 mg of famotidine, 10 Bags of One 2mL Single Dose Vial Each, For the Preparation of IV Solutions, **** NDC # 55390-029-10. Recall # D-230-5.
CODE
Lot 045715, exp. 04/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letter, dated April 25, 2005.
Manufacturer: Ben Venue Labs, Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
180 boxes/10 vials per box.
DISTRIBUTION
GA.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Haloperidol Oral Solution USP, (Concentrate), 2mg/mL, * NDC 0121-0581-04, NSN 6505-01-003-5341 * For Dropper Dosage Only, Each mL contains: 2mg Haloperidol (as the lactate0 * Rx Only * 4 fl oz (120mL). Recall # D-226-5.
CODE
Lot 4K55 and 4L72.
RECALLING FIRM
Pharmaceutical Associates, Inc., Greenville, SC, by fax on April 12 & 13, 2005, and by letter on April 14, 2005. Firm initiated recall is ongoing.
REASON
Labeling: When the screw cap dropper assembly is placed into the product the integrity of the ink used to identify the dosage levels may be compromised over time. As a result, the dosage markings may either be difficult or impossible to read.
VOLUME OF PRODUCT IN COMMERCE
17,367 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Biore PORE PERFECT Warming Anti-Blackhead Cream Cleanser Heats & Treats******Salicylic Acid OTC Acne Treatment Oil-Free, 6.25 oz (177g), Stock #03017, packed in shipping cases containing 12 x 6.25 oz tubes per case. The outer cartons and some tubes inside the shipping cartons are labeled as listed above, and all of the tubes contain the above referenced product; however, some tubes containing anti-blackhead cream cleanser are labeled as follows: Biore PORE PERFECT Pore Unclogging Scrub exfoliates & refines****** Salicylic Acid Acne Treatment, Oil-Free 5 oz (141 g). Recall # D-231-5.
CODE
Lot Numbers: T034CB02, T035CB02,04 & T035CB03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kao Brands Company, Cincinnati, OH, by letter dated March 23, 2005.
Manufacturer: Medicia Corp., Dayton, NJ. Firm initiated recall is ongoing.
REASON
Mispackaging: Shipping cartons distributed, which were labeled as containing one OTC product [Anti-blackhead Cleanser] but cartons contain retail tubes of product labeled as containing another OTC product [Pore Unclogging Scrub].
VOLUME OF PRODUCT IN COMMERCE
51,648 tubes.
DISTRIBUTION
Nationwide.

______________________________

PRODUCT
PEG-Intron Redipen (Peginterferon alfa-2b), 80mcg/.5mL, For Subcutaneous Use, Rx only, NDC 0085-1316-01. Recall # D-232-5.
CODE
Lot 3-IRG-303 exp. May 2006.
RECALLING FIRM
Schering Plough Corp, Kenilworth, NJ, by letter on April 22, 2005. Firm initiated recall is ongoing.
REASON
Labeling: Needles in the kit have an expiration date that is earlier than the expiration date of the PEG-Intron Redipen itself.
VOLUME OF PRODUCT IN COMMERCE
23,226 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0998-5.
CODE
Unit number: 0415261.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by letter, dated February 21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced. Recall # B-1010-5.
CODE
Units: 26KM26856, 26KM24219, 26KM22400.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Gulf Coast Region, Mobile, AL, by letter, dated December 17, 2002. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who had previously tested reactive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL, and AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1037-5.
CODE
Unit number: 4574634.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 19, 2003. Firm initiated recall is complete.
REASON
Blood product 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
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1045-5.
CODE
Unit numbers: 06FE67715, 06FE69512.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern California Region, Pomona, CA, by letters, dated March 30, and April 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1061-5.
CODE
Unit numbers: 9455499, 7769028, 7768962, 7768316, 7769185, 7769172, 7768699, 7768210, 7769203, 7769396, 7769409, 7751988, 7751957, 7768798, 7768976, 7768867, 7768700, 7768920, 7751983, 7751976, 7769133, 7759243, 7751933, 7769267, 7768779.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Jackson, TN, by telephone on August 26, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1076-5.
CODE
Unit numbers 0360026786, 0360027056.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on August 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1077-5.
CODE
Unit numbers 360039169, 360039257, and 360040492.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1079-5.
CODE
Unit numbers 360008967, 360009388, and 360009605.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1080-5.
CODE
Unit numbers 0360039709, 0360038954, 0360038562, and 0360038300.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on July 28, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1081-5.
CODE
Unit numbers 360034617, 360035095, 360035411, 360035863, and 360036164.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1083-5.
CODE
Unit numbers: 81398430, 81393015, 81375776, 81370962, 81366095, 81355358, 81348909, 81206964, 66241812, 66235477, 66232551, 66226314, 66223443, 66217602, 66209867, 66204039, 66198284, and 66195009.     
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by facsimile on January 15, 2003.
Manufacturer: ZLB Bioplasma, Inc, Gresham, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1085-5.
CODE
Unit numbers: 66168317, 66172185.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, 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 a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1088-5;
b) Platelets. Recall # B-1089-5.
CODE
a) Unit numbers: 19GW17900, 19GZ19698, 19GJ34204,
and 19GN14987;
b) Unit number: 19GW17900.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by letter, dated July 8, 1997. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to the use of the medication, Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1095-5.
CODE
Unit numbers: 194421, 194753, 195244, 117749, 116175, 338319, 116402, 338380, 116889, 388250, 117598, 388431, 117233, 388656, 388971, and 388961.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., San Angelo, TX, by facsimile on February 6, 2002. 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
16 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1121-5.
CODE
Unit number: SX006203.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, L.P., San Marcos, TX, by facsimile on July 26, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was collected from an ineligible due to previous reactive testing for anti-HCV, was distriburted.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1122-5.
CODE
Unit number 4763267.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated. Recall # B-1123-5.
CODE
Unit number 4731245.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 30, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1124-5.
CODE
Unit number 30656-1786 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter on February 19, 2004.
Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ND, and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1128-5.
CODE
Unit number 01BNDB7845.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Bismarck, ND, by facsimile on January 14, 2002. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have resulted in saline contamination of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-1130-5.
CODE
Unit numbers 02MWIB9905 and 02MWIB9992.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Menasha, WI, by facsimile on May 21, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-1131-5.
CODE
Unit numbers 118616, 118816, 119062, 119214, 119486, 337637, 337882, 338085, 338336, 388562, 388757, 388966, 389177, 389403, 389634, 389853, 390187, 390398, and 390670.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., San Angelo, TX, by facsimile on February 6, 2002. 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
19 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1132-5.
CODE
Unit number SX038639.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Marcos, TX, by facsimile on July 21, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1133-5.
CODE
Unit numbers: OT302212, OT301704, OT301476, OT300996, OT300890, OT300401, OT300332, OT299803, OT299515, OT299142, OT298911, OT298500, OT298265, OT297844, OT297599, OT297177, OT296894, OT296519, OT296294, OT295881, OT295618, OT295221, OT294979, OT294575, OT294305, OT293914, OT293689, OT293374, OT293121, OT292792, OT292574, OT292284, OT292055, OT291626, OT291458, OT287071, OT286814, OT286472, OT286121, OT285919, OT285364, OT285211, OT284621, OT284413, OT284108, and OT283929.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, L.P., Odessa, TX, by facsimile on February 3, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1134-5.
CODE
Unit number: 19LF04677.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on September 8, 1997. Firm initiated recall is complete.
REASON
Blood product, that tested positive for the Kell red blood cell antigen, but was labeled as Kell antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1137-5.
CODE
Unit numbers: 6417705, 6416855, and 6418495.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on November 10, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1143-5.
CODE
Unit numbers ST154044, ST274228, ST273296, ST272953, ST272460, ST272151, ST260563, and ST259943.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on November 20, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were 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
8 units.
DISTRIBUTION
NC, and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1147-5.
CODE
Unit numbers SX102319, SX102258, and SX101991.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Marcos, TX, by facsimile on June 30, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1148-5.
CODE
Unit numbers: SX065909 and SX067365.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Marcos, TX, by facsimile on July 21, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC, and NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1149-5.
CODE
Unit number: SX009225.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Marcos, TX, by facsimile on July 22, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1150-5.
CODE
Unit number 4406395.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1151-5.
CODE
Unit number 4599999.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 5, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Source Plasma. Recall # B-1297-5.
CODE
Unit numbers 50011505, 50012075, 50012994, 50013515, 50013992, 50014506, 50014686, 50015077, 50015256, 50015713, 50028241, and 50028441.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX , by facsimile on August 5, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Blood Cells, Leukocytes Reduced.
Recall # B-1299-5;
b) Recovered Plasma. Recall # B-1300-5.
CODE
a) and b) Unit number 1388809.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc. Orlando, FL, by facsimile on August 19, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1301-5.
CODE
Unit numbers 93866200, 93860567, 93658447, 93652919, 93179775, 93176514, 93172516, 93028660, 93023276, 93021432, 92708952, 92706897, and 93861939.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on July 21, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to possible intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1302-5;
b) Platelets, Leukocytes Reduced. Recall # B-1303-5.
CODE
a) and b) Unit number FM98548.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on March 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
RI.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1125-5;
b) Platelets. Recall # B-1126-5;
c) Fresh Frozen Plasma. Recall # B-1127-5.
CODE
a), b), and c) Unit number 0673238.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on April 3, 2003.
Manufacturer: Blood Centers of the Pacific, Peninsula South Bay Center, Burlingame, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1129-5.
CODE
Unit numbers 00BNDB3831, 00BNDB3833, 00BNDB3834, 00BNDB3835, 00BNDB3836, 00BNDB3837, 00BNDB3839, 00BNDB3840, 00BNDB3843, 00BNDB3845, 00BNDB3846, 00BNDB3848, 00BNDB3850, 00BNDB3855, 00BNDB3856, 00BNDB3857, 00BNDB3858, 00BNDB3859, 00BNDB3861, 00BNDB3863, 00BNDB3865, 00BNDB3866, 00BNDB3867, 00BNDB3868, 00BNDB3869, 00BNDB3871, 00BNDB3872, 00BNDB3875, 00BNDB3876, 00BNDB3878, 00BNDB3880, 00BNDB3881, 00BNDB3882, 00BNDB3883, 00BNDB3885, and 00BNDB3950.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Bismarck, ND, by facsimile on August 8, 2001. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units.
DISTRIBUTION
Austria.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) LifeScan brand OneTouch Ultra Blood Glucose Meter.
Recall # Z-0821-05;
b) LifeScan brand OneTouch FastTake Blood Glucose Meter.
Recall # Z-0822-05;
c) LifeScan brand InDuo Blood Glucose Meter.
Recall # Z-0823-05;
CODE
ALL CODES: All lot numbers and serial numbers.
RECALLING FIRM/MANUFACTURER
Lifescan Inc, Milpitas, CA, by letters on April 11, 2005. Firm initiated recall is ongoing.
REASON
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6.0M units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Simplastin HTF? Reagents, 20ml H2O, (and 6 ml H2O). Product numbers 259846, 259847. Recall # Z-0843-05.
CODE
Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc, Durham, NC, by letter on/about March 7, 2005. Firm initiated recall is ongoing.
REASON
The ISI labeling for Simplastin? HTF on the Coag-a-Mate? MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
VOLUME OF PRODUCT IN COMMERCE
19,748 kits.
DISTRIBUTION
Nationwide, Canada, Columbia, India, Philippines, Spain and Thailand.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS II

_______________________________
PRODUCT
Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress). Recall # Z-0844-05.
CODE
Unit Serial Numbers 1020V0503E00174 1020V0304E00058 1020V0403E00145 1020V0203E00102 1020V0503E00088 1020V0403E00153.
RECALLING FIRM/MANUFACTURER
AMF Support Surfaces, Inc., Corona, CA, by letters dated January 28, 2005. Firm initiated recall is ongoing.
REASON
Operator misconnected device power cords causing failure of the device.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IN, MD, and ND.

_______________________________
PRODUCT
Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Recall # Z-0845-05.
CODE
Product code 2C6255, lot R04J12126; Product code 2C8428, lot R04J11318; Product code 2C8515, lot R04J12043; Product code 2C8519, lots R04J12076, R04J12159; Product code 2C8537, lots R04J11128, R04J11201, R04J12027, R04J12084, R04J12183, R04J13033, R04J13116, R04J13173, R04J14031, R04J14098, R04J14130, R04J14155, R04J15061; Product code 2C8546, lot R04J11177; Product code 2C8571, lot R04J14205; Product code 2C8606, lot R04J13025; Product code 2C8612, lot R04J12019; Product code 2C8632, lot R04J12258; Product code 2C8634, lot R04J13090; Product code 2C8819, lots UR241323, UR242560, UR242669; Product code 2C8864, lot UR240697; Product code 2C8865, lots UR241638, UR241786, UR244012; Product code A2C9801, lots UR244020, UR245647; Product code 2H8401, lot R04J12068; Product code 2H8519, lots R04J15053, R04J16010; Product code 2N8371, lot UR245027; Product code 2N8373, lot UR243501; Product code 2N8374, lots UR229138, UR229526, UR230193, UR230193X, UR230433, UR230458, UR240747, UR241059, UR241356, UR241505, UR242065, UR246033; Product code 2N8378, lots UR229344, UR229781, UR230060, UR241133, UR241661, UR242107, UR242131, UR242362, UR242644, UR244632; Product code 2N8399, lots UR230128, UR230573, UR231027, UR231704, UR239301, UR239889, UR240200, UR240945, UR241265, UR242081, UR242230, UR243576.
RECALLING FIRM
Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL, by letters dated February 28, 2005.
Manufacturer: Baxter Healthcare, Corp. of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
REASON
Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
VOLUME OF PRODUCT IN COMMERCE
1,171,116 sets.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Altaire, Magnetic Resonance Imaging Device. Recall # Z-0846-05.
CODE
Serial numbers: L001 to L191.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America, Inc., Twinsburg, OH, by site inspections beginning on November 19, 2004. Firm initiated recall is ongoing.
REASON
The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
VOLUME OF PRODUCT IN COMMERCE
189 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Fresh Look * Radiance? * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * The product has been distributed in twin packs containing six pairs of lenses. Recall # Z-0847-05.
CODE
Lot #124637.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corp., Duluth, GA, by letters on April 21, 2005.
Manufacturer: Ciba Vision Corp., Des Plaines, IL. Firm initiated recall is ongoing.
REASON
The actual power of the lenses may be different from what is indicated on the package labeling.
VOLUME OF PRODUCT IN COMMERCE
2,250 units.
DISTRIBUTION
Nationwide and Europe.

_______________________________
PRODUCT
Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05.
CODE
Software Versions A.03.00 or lower and B.04.00 and lower.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on May 2, 2005. Firm initiated recall is ongoing.
REASON
The device may disarm and not deliver shock when performing a Synchronized Cardioversion.
VOLUME OF PRODUCT IN COMMERCE
5,125 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D). Recall # Z-0849-05.
CODE
All codes.
FIRM/MANUFACTURER
Edwards Lifesciences Llc, Irvine, CA, by voice mail and letters on April 28, 2005 and May 2, 2005. Firm initiated recall is ongoing.
REASON
Potential for deployment difficulties.
VOLUME OF PRODUCT IN COMMERCE
537 units.
DISTRIBUTION
Nationwide and Europe.

END OF ENFORCEMENT REPORT FOR May 25, 2005

###