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U.S. Department of Health and Human Services

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Enforcement Report for January 12, 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.

January 12, 2005
05-02

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Fort Fudge Shop brand Vanilla Nut Fudge sold in 6 ounce packages. Recall # F-123-5.
CODE
All purchases made between August 2003 and June 2, 2004.
RECALLING FIRM/MANUFACTURER
Fort Fudge Shop, Mackinaw City, MI, by press release issued June 4, 2004 and telephone on June 8, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
50 pounds.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Organica Double Chocolate Coffee Toffee Cookies, 6.5 oz packages. Recall # F-124-5.
CODE
Lot numbers 20705, 31905, 32005, 42905, 60205. Printed on bottom of cartons on a sticker.
RECALLING FIRM/MANUFACTURER
Bloomfield Bakers, Los Alamitos, CA, by letter and press release on November 24, 2004, Firm initiated recall is ongoing.
REASON
The product contained undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
25,476.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Great Value brand White Sandwich Bread, 24 oz.
Recall # F-125-5;
b) Great Value brand White Round Top Bread, 16 oz.
Recall # F-126-5;
c) Great Value brand Split Top White Bread, 24 oz.
Recall # F-127-5.
CODE
a) Sell by Dates of September 20th through
October 4th and Code numbers 22264 to 22278.
b) Sell by dates of September 20th thru October
4th and the Code Numbers 22264 to 22278;
c) Sell by Dates of September 20th through
October 4th and code numbers 22264 to 22278.
RECALLING FIRM/MANUFACTURER
Interstate Brands Corp, Pomona, CA, by telephone, email and press release issued on October 7, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared allergen, whey.
VOLUME OF PRODUCT IN COMMERCE
5,798.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Mushroom Soy Sauce, 5 pound plastic jugs. Recall # F-121-5.
CODE
Expiration date of 22 05 2006.
RECALLING FIRM/MANUFACTURER
Cf Group, Yorba Linda, CA, by letters on or about December 14, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
468 jugs.
DISTRIBUTION
OK, AR, MO, KS, TX.

_______________________________
PRODUCT
Father Sam's Spinach Wraps, 6 count package. Net Wt 13 oz. Sold in plastic bags. Keep refrigerated or frozen after opening. Firm on the label: "BAKED ESPECIALLY FOR YOU BY: FATHER SAM'S BAKERY". Sold in trays/12 packages per tray, and also sold to one consignee frozen, 18 packages per case. Recall # F-122-5.
CODE
Pull dates 11/10/2004 thru 11/21/2004, and lot # 090204. Codes varied depending on the consignee shipped to.
RECALLING FIRM/MANUFACTURER
Commitment 2000, Inc., Buffalo, NY, by letters dated September 8, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared colors, FD&C Yellow #5 and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
4,347 units (6/10" wraps).
DISTRIBUTION
NY and PA.

_______________________________
PRODUCT
a) Orange fruit juice drinks packaged in 1 gallon
plastic bottles labeled in part:
"***JONLLY***Light***NutraSweet***CHINA******
1Gal***" Recall # F-130-5;
b) Fruit Punch packaged n 1 gallon plastic bottles
labeled in part: "**JONLLY**Light**NutraSweet**
FRUIT PUNCH***1 Gal***" Recall # F-131-5.
CODE
a) China(orange) light: Nov 6/04 and Nov 7/04;
b) Fruit light - Nov 8/04.
RECALLING FIRM/MANUFACTURER
JONLLY FRUITS, INC., Bayamon, PR, by visit beginning on August 27, 2004. Firm initiated recall is ongoing.
REASON
a) The product contains undeclared color, FD&C Yellow # 5;
b) The product contains undeclared color, FD&C Yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
225 gallons.
DISTRIBUTION
PR.

_______________________________
PRODUCT
a) Frozen peas in various brands and package sizes
(day code 176): BEST YET brand GREEN PEAS
DISTRIBUTED BY FLEMING COMPANIES, INC. in 32 oz.
plastic bags, 12/case;
FLAV R PAC GRADE A FANCY GREEN PEAS, DISTRIBUTED BY
NORPAC FOODS, INC., in 40 oz. plastic bags and 20 lb.
poly lined boxes;
WESTPAC FROZEN GREEN PEAS DISTRIBUTED BY NORPAC FOODS
INC., in 20 lb. poly lined boxes;
VALLEY MAID GREEN PEAS DISTRIBUTED BY NORPAC FOODS
INC in 20 lb. poly lined boxes;
Roche Bros. Fancy Sweet Peas Distributed by Roche
Bros., Inc., Wellesley, MA in 16 oz. plastic bag,
12/case; unlabeled bulk totes, 1700 lbs. Day code 174:
FOOD LION Green Peas, DISTRIBUTED BY FOOD LION, LLC
in 10 oz. plastic bags, 24.case. Recall # F-133-5.
b) Frozen peas & carrots, Pathmark brand, 40 oz.
plastic bags. Recall # F-134-5.
CODE
a) Product packed from day code 176 includes:
Best Yet coded 31974A, 31974B;
Roche Bros. coded 52184C, 52184D, 52184E;
Flav-R-Pac, 40 oz. coded TJ4-18A3, TJ4-18B3,
TJ4-C3, TJ4-D3, TK4-15B, TK4-15C, TK4-15D,
TK4-22 D3, TL4-05A3, TL4-05B3, TL4-05C3,
TL4-05D3, TL4-16A3, TL4-16B3, TL4-19A3,
TL4-19B3, TL4-19C3, TL4-19D3, TL4-30C3,
TL4-30D3,
FLAV-R-PAC 20 lb coded TJ4-28A3;
WestPac coded TJ4-28A3, TJ4-28B3, TJ4-28C3,
TJ4-28D3;
Valley Maid coded TL4-09A3 Product packed
from day code 174: Food Lion coded 52244A;
b) 52244A (packed from day code 174).
RECALLING FIRM/MANUFACTURER
Twin City Foods Inc, Stanwood, WA, by letters on September 26, 2004. Firm initiated recall is complete.
REASON
Products are contaminated with Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
12,343 cs, plus 5100 lbs. bulk totes.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Sam's Choice Purified Drinking Water. 20 FL OZ (1.25PT) 591 mL. With flavor enhancing minerals. 24 bottles per case. Recall # F-128-5.
CODE
PROD090204WL EXP090206.
RECALLING FIRM/MANUFACTURER
Cott Beverages, Tampa, FL, by e-mail beginning on October 7, 2004. Firm initiated recall is complete.
REASON
The product is unfit for food due to off-odor and off-taste from contamination with mold and bacteria.
VOLUME OF PRODUCT IN COMMERCE
6048 cases.
DISTRIBUTION
NC, SC, KY, VA, WV, OH and TN.

_______________________________
PRODUCT
Nestea, COOL Lemon Iced Tea, 12 fl.oz. (355mL) can, Natural Flavored Sweetened Iced Tea. Product is packed in 12 and 6 packs. Recall # F-129-5.
CODE
Lot No. FEB1405DD E, MAR1405DD D, APR1805DD F, MAY0905DD B, C, D &E, MAY2305DD D, JUN1305DD E, JUL0405DD C, JUL2505DD E and AUG2205 DD C.
RECALLING FIRM/MANUFACTURER
Coco Cola Company, Atlanta, GA, by visit and letter starting December 2, 2004. Firm initiated recall is ongoing.
REASON
The product is fermented due to improper sanitation procedures of processing machinery..
VOLUME OF PRODUCT IN COMMERCE
302477 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Mead Johnson Nutritionals brand Enfamil LactoFree with LIPIL milk-based infant formula, lactose-free, iron fortified, concentrated liquid in a 13 fl. oz. can. Sold in cases of 12 cans each; case UPC 3-0087-0614-01. Recall # F-132-5.
CODE
USE BY 1 AUG 04/ LACLIP/ AGA29.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Company, Evansville, IN, by letter dated December 9, 2003. Firm initiated recall is complete.
REASON
May have an off-odor, clumping and product separation.
VOLUME OF PRODUCT IN COMMERCE
6408 cases.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Peri-Colace Tablets. (8.6 mg Sennosides and 50 mg Docusate Sodium), 60 count bottles, Dist. by Purdue Products, Stamford, CT 08901, NDC 67618-106-60. Recall # D-104-5.
CODE
Lot 4C7985 Exp. Date March 31, 2006.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letter on November 23, 2004. Firm initiated recall is ongoing.
REASON
Presence of Foreign Tablet: One red tablet (Peri-Colase generic manufactured under the Time Capsules Lab label) was found in a 60 count bottle of Peri-Colase burgundy tablets.
VOLUME OF PRODUCT IN COMMERCE
25,196 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Haemonetics Mobile Collection Systems. Recall # B-0362-5.
CODE
MCS+ 9000, MCS+ 7000, MCS+8100
Model Numbers: LN 09000-110-E, LN 07000-110-E, LN 08100-110-E
RECALLING FIRM/MANUFACTURER
Haemonetics Corporation, Braintree, MA, by letters dated October 18 through 26, 2004. Firm initiated recall is on going.
REASON
Apheresis systems, with possible leaks in the base of the collection bowl, were distributed.
VOLUME OF PRODUCT IN COMMERCE
651 instruments distributed.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0366-5.

CODE
Unit 6501457.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by telephone on October 20, 2003. Firm initiated recall is complete.
REASON
Blood product, for which the donor history record could not be located, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0367-5;
b) Cryoprecipitated AHF. Recall # B-0368-5.
CODE
a) and b) Unit 6516764.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by letter dated August 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0378-5.
CODE
Units SX040744, SX041990, SX051611, and SX051808.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., San Marcos, TX, by facsimile on January 29, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received tattoos within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0414-5.
CODE
Unit 0792207.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated October 1, 2002. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.     
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0415-5.
CODE
Unit 0850085.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific,  San Francisco, CA, by letter dated October 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0422-5.
CODE
Unit FE75817.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by phone on October 28, 2004. Firm initiated recall is complete.
REASON
Blood Product, which was labeled as leukoreduced, but did not meet the requirements of a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0423-5.
CODE
Unit 9591005.
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by phone on September 30, 2004. Firm initiated recall is complete.
REASON
Blood Product, which was leukoreduced twice, was distributed.     
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets. Recall # B-0424-5.
CODE
Unit S79273.
RECALLING FIRM/MANUFACTURER
Blood Product, collected during a blood drive where donor confidentiality was compromised, was distributed.
REASON
Michigan Community Blood Center, Saginaw, MI, by fax on October 29, 2004. Firm initiated recall is complete.    
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0438-5.
CODE
Unit 02MWIC3094.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Menasha, WI, by facsimile transmission dated May 9, 2002. Firm initiated recall is complete.
REASON
Source Plasma, untested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
a) Platelets. Recall # B-0446-5;
b) Fresh Frozen Plasma. Recall # B-0447-5.
CODE
a) Unit 4611799;
b) Units 4630734, 4616507, 4611799.
RECALLING FIRM/MANUFACTURER
Anne Arundel Medical Center Blood Bank, Annapolis, MD, by letter dated July 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.         
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0461-5;
b) Plasma, Frozen, Recall # B-0462-5.
CODE
a) and b) Unit 029KN39416.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region,
Norfolk, VA, by phone and letter on October 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and NC.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0478-5.
CODE
Unit KS35801.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services,    Blood Donor Services, Annandale, VA, by letter dated August 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0480-5. 
CODE
Unit 53GQ15850.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on May 19, 2004 and by letter dated May 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0481-5.
CODE
Unit 8737305.
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital Blood Bank, Baltimore, MD, by letter dated July 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.  
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Human Cornea Tissue. Recall # B-0483-5.
CODE
Tissue # 2004-11-43.
RECALLING FIRM/MANUFACTURER
Wichita Eye Foundation, Wichita, KS, by letter dated December 8, 2004. Firm initiated recall is complete.
REASON
Human cornea, collected from a donor who subsequently tested positive for HBsAg by another tissue procurement organization, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MO.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0484-5.
CODE
Unit number: 306597709.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Fargo, ND, by telephone on May 3, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a positive bacterial culture, was distributed.          
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0501-5.
CODE
Unit 04LJ07344.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and letter on September 1, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who resided in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0502-5.
CODE
Unit 04FK55245.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and letter on October 19, 2004.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0511-5.
CODE
Units 261195892, 261195900-1, 261195900-2, 261195903-1, 261195903-2, 261195918-1, 261195918-2, 261195933, 261195934, 261195936, 261195941, 261195943-1, 261195943-2, 261195949, 261195950, 261195952-1, 261195952-2, 261195954, 261195959, 261195979.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Texarkana, TX, by telephone on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors with unacceptable hematocrit determinations, were distributed.     
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
AK and TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0512-5.
CODE
Units 0856738, 0860676, 0857476-1, 0857476-2.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by facsimile on December 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on travel to areas considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Red Blood Cells Leukoreduced. Recall # B-0513-5.
CODE
Units: 150224432, 150224070, 150225011, 150224132, 150224661.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lubbock Center, Lubbock, TX, by telephone on August 25, 2003, fax on September 3, 2003 and letter dated September 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested positive for West Nile Virus, were distributed.        
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0516-5.
CODE
Unit number: E94664.
RECALLING FIRM/MANUFACTURER
HCSC - Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by letter, dated September 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with diarrhea, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0517-5.
CODE
Unit 0919628.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated November 3, 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
NJ.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0521-5.
CODE
Unit 0894248.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone and facsimile on March 26, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0376-5.
CODE
Units 21KC75460, 21KC75476, 21KC75649, 21FS30800,
21FZ11658, 21FZ11681, 21W56857, and 21K87030.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on August 14, 2003 and by letter dated August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0377-5.
CODE
Units E84790, E92559, E85655, E93320, E91653, and E91559.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by letter dated September 10, 2004. Firm initiated recall is complete.
REASON
Blood products, which exceeded the manufacturer's acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0425-5.
CODE
Units:
45690013 56761191 57260723 57265018 57267876 59324201 56766028 62338608 44975432 44978969 46515681 46518309 41604441 41601617 71542478 71662060 41606872 41609163 41610398 63066258 57265353 56533217 59337614 41608999 59331513 59334293 56533514 56534979 41506479 46510631 45681295 45683336 46519283 41509326 59718055 59326960 41602898 41606025 71664767 44973322 45685477 44973230 41602096 45681455 45682940 59713289 46519009 56765564 60684103 44980504 57266770 41604274 41505359 41505854 41601112 62344432 44979256 41603949 41506110 41601327 41604090 41604748 59336020 41508343 41600580 41601204 46512772 44977078 41603826 41601631 41610367 44971755 44971359 59321019 59322191 44974244 56462296 46514226 46516091 57265155 44975760 44972448 44975746 44975753 46517319 44971694 44975692 44978990 59326601 59331568 46517289 56534122 56537079 44972974 71660783 44972868 44973421 44975111 44978372 45690143 46512659 56761047 57264141 44978075 46511539 46511010 63066821 46514196 56539134 44980450 56469028 46517692 44979317 46511751 46512789 62966856 57261553 59323129 71550176 71663548 71665665 57262314 56765519 60681645 46516008 57264127 56470437 56533293 57268354 56462746 56464351 56531152 59325369 45685903 56537574 56539578 45690235 57264660 45688164 45690372 56761658 71669991 71548098 45690228 45683268 45687365 56468106 56469820 59712022 57263847 57266756 57268156 56533903 62108577 62348638 57265063 56461879 56464382 56466287 57263571 59331728 56533958 57262871 59325086 57266411 57268392 60546111 56468939 57267524 56468977 62108560 62332316 56533736 59340317 56530865 56470161 56462647 56765861 56463910 56466430 56536409 56470307 56535051 56760835 56465952 62984522 71547534 62105019 56536294 56534559 56537338 56469714 56539677 56535464 56538120 56530827 56767216 62335423 62984102 56763553 56535013 56534962 59320975 59324591 59325888 56767148 62342681 62344241 56761290 56766370 56768237 56767759 56767957 56767711 59321873 59326144 56767414 62342643 62963985 60547514 59325338 59324850 59324652 60545671 59331216 56767926 56770407 59331674 59711179 59337492 71540610 71542119 59336136 60541581 59339601 59339595 62961011 60545961 59334187 60545565 60543141 60545381 62104685 59340065 60544063 62335874 60544384 60684769 60687500 62103817 60682932 60682949 62346023 71666358 62984966 62987530 63065459 71664583 62102124 62337083 60689450 62102469 62108478 59711148 62335898 59711889 59712008 60687135 60690340 62337403 59719335 60689276 71547718 59712428 62331579 71666303 62102766 62333061 62337052 62102476 62337366 62101608 59718208 62101844 62343671 62333900 62109666 62101387 62337113 62333320 62334976 62333276 62335744 71546087 62968560 62331548 62966849 62110471 62333337 63070019 63069358 63070026 62335515 62965293 62969529 62963145 62968461 63061000 63068009 62969857 62987073 62983907 62988971 62968324 63067576 62983587 62983532 63064841 63065176 63067255 71550442 63068313 63070163 63066920 63068641 71667232 63066913 63068665 71547879 63064858 63066227 63067170 71542379 71666938 71665580 71546261 71661698 71664590 71663098 71547176 71664576 71664828 71669250 71781518
02PVAB4062 02PVAB4197 03PVAA0436 02PVAA0024 02PVAA9012 02PVAA5666 02PVAA1371 02PVAA1490 02PVAA1878 02PVAA2575 02PVAA2928 02PVAA4775 02PVAA0592 02PVAA1261 02PVAA2840 02PVAB4055 02PVAA2769 02PVAA2844 02PVAA2884 02PVAA2946 02PVAA6110 02PVAA0947 02PVAB0006 02PVAB0854 02PVAA9170 02PVAA0310 02PVAA3062 02PVAB3834 02PVAA2725 02PVAA0596 02PVAA6496 02PVAA0284 02PVAA2209 02PVAA9352 02PVAA2855 02PVAA5339 02PVAA2260 02PVAA6478 02PVAA2624 02PVAB2680 02PVAA3879 02PVAB1587 02PVAA6508 02PVAA8028 02PVAB2826 02PVAB3485 02PVAA6513 02PVAA9662 02PVAB0011 02PVAB0514 02PVAA9168 02PVAB3356 02PVAB6592 02PVAB3025 02PVAB0648 02PVAB5656 02PVAB1690 02PVAB3179 02PVAB5280 02PVAB6533
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Portsmouth, VA, by faxes between March 20, 2003, and March 25, 2003. Firm initiated recall is complete.
REASON
Blood Products, collected from donors whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
404 units..
DISTRIBUTION
CA, MI, and NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0437-5.
CODE
Unit numbers: 75996406, 75997823, 76323362.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Petersburg, VA, by facsimile on
June 26, 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
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0500-5.
CODE
Unit number: 004LJ10812.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by telephone on October 12, 2004, and by letter, dated October 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled as being negative for unexpected antibodies, was distributed.     
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0514-5.
CODE
Unit numbers: 153971132, 153964803, 153970930, 153969892, 153972645, 153972594, 153970929, and 153970960.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by letters, dated July 17, 2003 and September 2, 2003, and by telephone on September 23, 2004 and November 1, 2004. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper shipping temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 Units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0515-5.
CODE
Unit number: 8099212.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by facsimile on April 23, 2004. Firm initiated recall is complete.
REASON
Blood product, exposed to unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Proteus XR/a Radiographic X-ray System; Precision 500D Radiographic/Fluoroscopic X-ray System
Use: Diagnostic Radiology. Recall # Z-0219/0220-05.
CODE
All.
RECALLING FIRM/MANUFACTURER
GE Healthcare Technologies, Waukesha, WI, by field service representative beginning on December 27, 2004. Corrections should be completed by May 2005. Firm initiated recall is ongoing.
REASON
The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(g) , Positive Beam Limitation (PBL).
VOLUME OF PRODUCT IN COMMERCE
Approximately 2250 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11". Model EX24D. Recall # Z-0306-05.
CODE
Lot No.: 58174875.
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Research Medical Inc, Midvale, UT, by letter on November 22, 204. Firm initiated recall is ongoing.
REASON
Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
VOLUME OF PRODUCT IN COMMERCE
396 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Easy Go Vac Aspirator, Model PM65.
Portable suction unit. Recall # Z-0307-05;
b) Easy Go Vac Aspirator, Model PM65HG.
Portable suction unit. Recall # Z-0308-05.
CODE
a) Serial Numbers:008360 to 14360 Charger
part number 503974 (Globtek Part #
TM21097CC-5015-1.3 Part No: GS-307-B);
b) Serial numbers 008360 through 14360
Charger part number 503974 (Globtek
Part # GTM21097CC-5015-1.3 Part No:
GS-307-B).
RECALLING FIRM/MANUFACTURER
Precision Medical, Inc. Northampton, PA, by letters on November 15, 2004. Firm initiated recall is ongoing.
REASON
Battery charger can be overcharged and overheat.
VOLUME OF PRODUCT IN COMMERCE
6,000 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Titanium Orthos Bracket. Recall # Z-0309-05.
CODE
Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
RECALLING FIRM/MANUFACTURER
Ormco Corporation, Glendora, CA, by letters from November 18 thru November 23, 2004. Firm initiated recall is ongoing.
REASON
Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
VOLUME OF PRODUCT IN COMMERCE
6,257.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Brand name: NIM? EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM? EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308. All products are packaged one unit per box. Recall # Z-0310-05.
CODE
Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400.
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, Fl, by letter on October 29, 2004. Firm initiated recall is ongoing.
REASON
The firm received six reports of tubes with wires "out of channel" two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
VOLUME OF PRODUCT IN COMMERCE
22,569 EMG Tubes.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. Recall # Z-0326-05.
CODE
All serial numbers beginning with C0424.
RECALLING FIRM/MANUFACTURER
Medical Industries America Inc, Adel, IA, by telephone on September 3, 2004 and on September 10, 2004. Firm initiated recall is ongoing.
REASON
Units could show an error code and stop functioning.
VOLUME OF PRODUCT IN COMMERCE
74 units.
DISTRIBUTION
Nationwide, Hong Kong, Chile, and Canada.

_______________________________
PRODUCT
a) 14 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners (15cm)
for Endoscopic Removal (list #00226).
Single Use Sterile Gastrostomy Kits.
Recall # Z-0327-05;
b) 18 French Ross Flexiflo Lap J Laparoscopic
Jejunostomy Kit with Brown/Mueller T-Fastener
Set (List #51174) Assorted Single Use Sterile
Jejunostomy Kits. Recall # Z-0328-05.
c) 14 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners (15cm)
for Endoscopic Removal (list #00227).
Recall # Z-0329-05;
d) 18 French Ross Flexiflo Over the Guidewire
Gastrostomy Basic Kit with T-Fasteners for
Endoscopic Removal (list # 00228).
Recall # Z-0330-05;
e) 18 French Ross Flexiflo Over the Guidewire
Gastrostomy Kit with T-Fasteners for
Endoscopic Removal (list # 00238).
Recall # Z-0331-05;
f) 18 French Ross Introducer Complete
Gastrostomy Kit with Brown/Mueller T-Fastener
Set (list # 50190). Recall # Z-0332-05;
g) 22 French Ross Versa-PEG Complete
Gastrostomy Kit, an Over-the-Wire
PEG Method Featuring Tube Removal
without Endoscopy (list # 50520).
Recall # Z-0333-05;
20 French Ross Over-the-Guidewire Basic
h) Gastrostomy KIt with Reinforced Webbed
Bumper for Endoscopic Removal (Basic)
(list # 50728). Recall # Z-0334-05;
i) 20 French Ross Flexiflo Over-the-Guidewire
Complete Gastrostomy KIt with Reinforced
Webbed Bumper for Endoscopic Removal
(list #50738). Recall # Z-0335-05;
j) 20 French Ross Inverta-PEG Over-the-
Guidewire Basic Gastrostomy KIt with
Roll-Tip Bumper (list # 51490).
Recall # Z-0336-05;
k) 20 French Flexiflo Inverta-PEG Pull
Technique Basic Gastrostomy KIt with
Roll-Tip Bumper (list # 52000).
Recall # Z-0337-05;
l) 10 French Ross Flexiflo Lap J
Laparoscopic Jejunostomy Kit with
Brown/Mueller T-Fastner Set
(list #51442). Recall # Z-0338-05.
CODE
a) Lots: 04639GZ00 and 17182GZ00;
b) Lots: 01528GZ00, 04666GZ00, 08764GZ00,
10840GZ00, 12921GZ00, 14003GZ00, 14019GZ00,
15080GZ00, 17178GZ00, 82485GZ00, 86727GZ00,
88827GZ00, 91053GZ00, 91157GZ00, 94377GZ00,
96466GZ00;
c) Lots: 01487GZ00, 15069GZ00, 94312GZ00;
d) Lots: 01504GZ00, 05675GZ00, 12916GZ00,
15079GZ00, 17181GZ00, 87766GZ00,
90001GZ00, 92215GZ00;
e) Lots: 02581GZOO, 11884GZ00, 17159GZ00;
f) Lots: 02565GZ00, 03600GZ00, 04643GZ00,
05676GZ00, 06719GZOO, 10829GZ00, 10860GZ00,
11893GZ00, 12943GZ00, 13960GZ00, 14011GZ00,
14052GZ00, 15089GZ00, 16134GZ00, 16143GZ00,
18206GZ00, 84569GZ00, 86700GZ00, 88826GZ00,
89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00,
93261GZ00, 94322GZ00, 95410GZ00, 96470GZ00;
g) Lots: 01511GZ00, 09769GZ00, 15086GZ00,
19243GZ00, 88824GZ00;
h) Lots 13959GZ00, 90997GZ00.
i) Lots: 02562GZ00, 04658GZ00, 07738GZ00,
12917GZ00, 15061GZ00, 89905GZ00,
96435GZ00;
j) Lots: 02560GZ00, 08753GZ00, 14028GZ00,
15116GZ00, 17156GZ00, 86714GZ00,
89941GZ00, 93281GZ00;
k) Lots: 04640GZ00, 07725GZ00, 20276GZ00,
85688GZ00, 89904GZ00;
l) Lot: 04622GZ00, 11870GZ00, 13978GZ00,
15105GZ00, 17165GZ00, 18190GZ00,
86722GZ00, 90044GZ00, 95381GZ00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Columbus, OH, by letter, dated November 12, 2004. Firm initiated recall is ongoing.
REASON
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34,073
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ACT diff 2 Analyzer (Automated differential cell counter). Recall # Z-0339-05.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, by letter on December 3, 2004. Firm initiated recall is ongoing.
REASON
Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
VOLUME OF PRODUCT IN COMMERCE
2,709 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems?, Catalog # 394236. Recall # Z-0340-05.
CODE
Lot 3504519.
RECALLING FIRM/MANUFACTURER
Weck, Research Triangle Park, NC, by letter on January 25, 2001. Firm initiated recall is complete.
REASON
An incorrect electrosurgical cord was included in some of the packages.
VOLUME OF PRODUCT IN COMMERCE
462 units.
DISTRIBUTION
Nationwide, Singapore.

_______________________________
PRODUCT
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05.
CODE
Software versions A.02.00 and lower.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on December 13, 2004. Firm initiated recall is ongoing.
REASON
In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy.
VOLUME OF PRODUCT IN COMMERCE
2,520 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Colleague Single Channel Volumetric
Infusion Pumps, product code 2M8151
and 2M8151R; Made in Singapore; monochrome
display screen. Recall # Z-0342-05;
b) Colleague 3 Triple Channel Volumetric
Infusion Pumps, product code 2M8153
and 2M8153R; Made in Singapore; monochrome
display screen. Recall # Z-0343-05;
c) Colleague CX Single Channel Volumetric
Infusion Pumps, product code 2M8161
and 2M8161R; Made in Singapore; color
display screen. Recall # Z-0344-05;
d) Colleague 3 CX Triple Channel Volumetric
Infusion Pumps, product code 2M8163 and
2M8163R; Made in Singapore; color
display screen. Recall # Z-0345-05.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated November 4, 2004. Firm initiated recall is ongoing.
REASON
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
VOLUME OF PRODUCT IN COMMERCE
199,456 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Hill-Rom CareAssist Bed; model P1170. Recall # Z-034605.
CODE
All units shipped prior to September 22, 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated November 29, 2004. Firm initiated recall is ongoing.
REASON
Warning label containing instructions for proper electrical grounding was not attached.
VOLUME OF PRODUCT IN COMMERCE
1,825 units.
DISTRIBUTION
Nationwide, Canada and Saudi Arabia.

_______________________________
PRODUCT
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Recall # Z-0347-05.
CODE
Serial numbers 0638851-0638871, expiration date October 2009.
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by telephone on November 2, 2004. Firm initiated recall is ongoing.
REASON
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. A Cemented Trapezoid Tibial Tray labeled as 4F/4T appeared to dimensionally be a 3F/3T.
VOLUME OF PRODUCT IN COMMERCE
21.
DISTRIBUTION
NJ, FL, MN, NY, MD, TX and the UK.

_______________________________
PRODUCT
Sunsoft Multiples Toric, methafilcon A, clear contact lens. Recall # Z-0348-05.
CODE
Lot Number 12981729.
RECALLING FIRM/MANUFACTURER
Ocular Sciences, Inc. Albuquerque, NM, by courier on December 9, 2004. Firm initiated recall is ongoing.
REASON
Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
VOLUME OF PRODUCT IN COMMERCE
46 lenses.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Amplatzer Delivery Systems (45-degree curve).
order no. 9-DEL-6F-45/60. Product is labeled
as Sterile EO. Amplatzer Occluder Device and
Delivery System is comprised of delivery
sheath, delivery cable, dilator, loading
device and pin vise. Recall # Z-0350-05;
b) AMPLATZER Delivery System 45-degree curve,
order no. 9-DEL-7F-45/60. Product is
labeled as Sterile EO. Amplatzer Occluder
Device and Delivery System is comprised of
delivery sheath, delivery cable, dilator,
loading device and pin vise. Recall # Z-0351-05;
c) AMPLATZER Delivery System 45-degree curve,
order no. 9-DEL-7F-45/80. Product is
labeled as Sterile EO. Amplatzer Occluder
Device and Delivery System is comprised
of delivery sheath, delivery cable,
dilator, loading device and pin vise.
Recall # Z-0352-05;
d) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-8F-45/60.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin vise.
Recall # Z-0353-05;
e) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-8F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery
cable, dilator, loading device
and pin vise. Recall # Z-0354-05;
f) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-9F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise. Recall #Z-0355-05;
g) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-10F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise. Recall # Z-0356-05;
h) AMPLATZER Delivery System 45-degree
curve, order no. 9-DEL-12F-45/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise. Recall # Z-0357-05;
i) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-5F-180/60.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise. Recall # Z-0358-05;
j) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-6F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery cable,
dilator, loading device and pin vise.
Recall # Z-0359-05;
k) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-7F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised
of delivery sheath, delivery
cable, dilator, loading device
and pin vise. Recall # Z-0360-05;
l) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-8F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin vise.
Recall # Z-0361-05;
m) AMPLATZER Delivery System 180-degree
curve, order no. 9-DEL-9F-180/80.
Product is labeled as Sterile EO.
Amplatzer Occluder Device and
Delivery System is comprised of
delivery sheath, delivery cable,
dilator, loading device and pin
vise. Recall # Z-0362-05;
n) AMPLATZER Exchange System 45-degree
curve, order no. 9-EXCH-9F-45/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery
sheath, delivery cable, dilator,
loading device and pin vise.
The only exception is the dilator
component in the Exchange System
has a larger inner lumen to allow
passage over an AMPLATZER delivery
cable. Recall # Z-0363-05;
o) AMPLATZER Exchange System 45-degree
curve, order no. 9-EXCH-12F-45/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery sheath,
delivery cable, dilator, loading
device and pin vise. The only
exception is the dilator component
in the Exchange System has a larger
inner lumen to allow passage over
an AMPLATZER delivery cable.
Recall # Z-0364-05;
p) AMPLATZER Exchange System 180-degree
curve, order no. 9-EXCH-6F-180/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System is
comprised of the identical components
as the AMPLATZER Delivery System,
which is comprised of delivery
sheath, delivery cable, dilator,
loading device and pin vise.
The only exception is the dilator
component in the Exchange System
has a larger inner lumen to allow
passage over an AMPLATZER delivery
cable. Recall # Z-0365-05;
q) AMPLATZER Exchange System 180-degree
curve, order no. 9-EXCH-8F-180/80.
Product is labeled as Sterile EO.
The AMPLATZER Exchange System
is comprised of the identical
components as the AMPLATZER
Delivery System, which is
comprised of delivery sheath,
delivery cable, dilator, loading
device and pin vise. The only
exception is the dilator component
in the Exchange System has a larger
inner lumen to allow passage over
an AMPLATZER delivery cable.
Recall # Z-0366-05.
CODE
a) 00E01-13, M02K07-44, M03C24-17,
M03E27-07, M03F18-09, M03L11-45,
M04B09-16, M04E27-19;
b) M01J08-12, M02D26-01, M02L11-20,
M03A09-12, M03B20-12, M03D16-24,
M03F18-08, M03L12-09, M04C23-09,
M04G01-24;
c) M01K01-6, M02C12-24, M02C25-15,
M02F05-23, M02F24-05, M02L02-21,
M03A09-10, M03A09-15, M03A20-10,
M03B20-17 M03C24-14, M03F02-17,
M03G23-08, M03H12-42, M03J19-07
M03K14-06, M03K28-35, M03L11-48,
M04B03-09, M04B03-14 M04C08-12,
M04D06-12, M04E11-28, M04E24-20,
M04F08-23 M04H03-23, M04J17-07,
M04K07-02;
d) M02D26-02, M02I23-02, M02J10-09,
M02K07-47, M03C04-06 M03D16-16,
M03F18-07, M03K14-07, M03L18-50,
M03M03-11 M04C23-10, M04E24-18,
M04G01-20;
e) M01J19-12, M02B14-10, M02C12-27,
M02D16-19, M02D16-23 M02F24-07,
M02G23-04, M02H19-05, M02K07-48,
M02K12-10 M02L11-13, M03A09-13,
M03A20-11, M03A20-18, M03A22-12
M03B10-56, M03B20-11, M03C24-13,
M03D08-08, M03D16-18 M03E27-08,
M03F13-07, M03F18-10, M03H12-43,
M03J04-12, M03J19-08, M03J25-27,
M03K09-23, M03K28-36, M03L11-46
M03M03-12, M03M29-07, M04A19-28,
M04A28-16, M04B03-13, M04B09-19,
M04B17-33, M04B24-08, M04C23-11,
M04D06-13 M04D26-06, M04D26-10,
M04F08-22, M04F28-47, M04H24-22
M04J07-09, M04J10-22, M04J17-08,
M04K15-10, M04L02-02;
f) M01K01-7, M01K28-18, M02C25-24,
M02D16-17, M02D16-21, M02E16-28,
M02F05-22, M02F24-08, M02G23-01,
M02G23-06, M02K07-51, M02K12-09,
M02K20-06, M02K25-13, M02L02-29,
M02L11-10, M02L11-15, M02L11-17,
M03A09-70, M03A27-34, M03A27-35,
M03B10-52, M03B10-55, M03B20-19,
M03C13-11, M03C13-13 M03C24-11,
M03G09-13, M03G24-19, M03G30-26,
M03H01-02, M03H05-17, M03H05-18,
M03H12-40, M03H15-03, M03H15-05,
M03H15-09, M03J02-16, M03J10-08,
M03J10-09, M03K14-08, M03K24-15,
M03K28-37, M03M02-12, M03M03-08,
M03M29-03, M03M29-06, M03M30-13,
M04A19-29, M04A28-18, M04B03-12,
M04B17-38, M04C08-13, M04C15-04,
M04C15-06, M04D06-09, M04D13-17,
M04D20-08, M04D26-07, M04D26-09,
M04E24-19, M04E27-24, M04F21-43,
M04F23-23, M04G27-25, M04H12-12,
M04H24-20, M04L05-08;
g) M01I13-3, M02E14-03, M02E16-24,
M02E16-30, M02F05-20, M02G10-04,
M02G23-05, M02H19-01, M02H30-01,
M02K07-03, M02K12-07, M02L02-24,
M02L02-27, M02L11-11, M02L19-08,
M03A09-16, M03A22-11, M03B10-53,
M03F13-06, M03F19-13, M03G10-37,
M03H08-06, M03H15-07, M03J04-05,
M03J17-05, M03J25-26, M03K01-02,
M03K09-22, M03K14-05, M03K16-16,
M03K16-17, M03K24-09, M03L18-56,
M03M30-11, M03M30-14, M03M30-15,
M04A19-30, M04B03-11, M04B17-34,
M04B24-09, M04C30-08, M04F08-20,
M04F23-20, M04F28-46, M04G01-19,
M04G01-21, M04H23-20, M04H23-21,
M04J07-04;
h) M01K01-1, M02D16-22, M02E16-25,
M02E16-29, M02G10-03, M02H30-02,
M02K07-37, M02K12-08, M02K20-08,
M02L02-28 M02L11-12, M02L19-07,
M03A09-17, M03A20-12, M03A22-14
M03B20-16, M03C04-05, M03D16-14,
M03G09-07, M03G10-36, M03H15-12,
M03H15-13, M03J12-02, M03J25-28,
M03K16-21, M03K24-13, M03L18-55,
M03M03-13, M03M30-12, M03M30-16,
M04A28-19, M04C09-03, M04C09-04,
M04C15-05, M04D01-04, M04D06-08,
M04D26-08, M04F21-42, M04F23-22,
M04G27-26 M04H03-22, M04H24-21;
i) M02A28-23, M03A09-11, M03B20-15,
M03H06-07, M03J19-05, M03L18-49,
M04B02-02, M04C01-19, M04E18-13,
M04J13-15;
j) M01B01-14, M01G05-7, M02A02-33,
M02A28-20, M02C12-26, M02D26-03,
M02D26-05, M02I23-01, M02K07-42,
M03A09-14, M03A20-13, M03A22-09,
M03B20-14, M03C24-15, M03D02-05,
M03D02-07, M03D08-10, M03D16-23,
M03D16-25, M03K16-22, M03K28-33,
M03L11-47, M03M02-09, M03M03-09,
M03M12-18, M04A19-31, M04B03-10,
M04C01-17,M04C23-12, M04D06-10,
M04D13-16, M04E24-16, M04F23-21,
M04F28-40, M04G01-22, M04G27-27,
M04H03-17, M04H12-11;
k) 00L14-6, M01K28-17, M01L17-06,
M02D16-18, M02D26-04, M02I13-02,
M02K07-04, M02K07-45, M02K12-11,
M03A22-13, M03C24-10, M03D02-06,
M03D02-08, M03D16-17, M03G10-31,
M03G15-34, M03K24-14, M03L12-10,
M03M12-19, M04B03-08, M04B09-17,
M04C01-18, M04D01-05, M04D06-11,
M04D20-07, M04E04-05, M04F08-21,
M04H03-18, M04H24-25;
l) M01L17-02, M02A28-21, M02A28-24,
M02K07-46, M03G10-30, M03L18-52,
M04B09-18, M04C23-13, M04E27-20,
M04F08-24, M04H03-20, M04K26-18;
m) M02A28-22, M02B25-05, M02B25-06,
M03C24-12, M03K28-34, M03L18-51;
n) M01L12-10, M03D08-06, M03D08-07,
M03L18-54;
O) M01B14-8, M02F05-18, M03A09-69,
M03E27-05, M03F18-12;
p) M02B14-09, M02C25-16;
q) M02A28-25, M04D01-06.
RECALLING FIRM/MANUFACTURER
AGA Medical Corporation, Golden Valley, MN, by letter November 22- 24, 2004. Firm initiated recall is ongoing.
REASON
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. Residue was determined to be EAP (Ethoxylated alkyl Phenol).
VOLUME OF PRODUCT IN COMMERCE
65,675 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Recall # Z-0367-05.
CODE
System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers BM25: all serial numbers Meridian: serial numbers 200101-203156.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letter dated December 14, 2004. Firm initiated recall is ongoing.
REASON
Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
VOLUME OF PRODUCT IN COMMERCE
2240.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Thoravision I Thorax and Mass Chest
Column. Part numbers 4512 130 07811.
Recall # Z-0369-05;
b) Thoravision II Thorax and Mass Chest
Column. Part numbers 4512 130 07812.
Recall # Z-0370-05.
CODE
a) The firm uses site numbers instead of
serial numbers. The listed site numbers
include both Thoravision I and II
products. 83956, 13253, 13917, 86223,
25709, 38975, 17579, 13610, 17506, 50321,
100322, 13919, 45032, 44803, 26294, 82617,
76802, 100633, 41354, 26058, 100693,
76806, X0212, 62971, 76374, 59408, 6960,
38715, 10405, 40932, 50319, 50320, 59670,
62972, 86451, X1068, 47101, 47167, 17620,
26214, 76020, 76021, 41437, 38989;
b) See the site numbers listed for the
Thoravision I. The listed site numbers
include both Thoravision I and II products.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter starting on December 1, 2004. Firm initiated recall is ongoing.
REASON
X-Ray system may fall downward and could possibly hit the patient.
VOLUME OF PRODUCT IN COMMERCE
44 total units (Thoravision I and II).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Part Number: 386167. Recall # Z-0371-05.
CODE
Lot Number: 04250160.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004, and by letter dated November 2, 2004. Firm initiated recall is ongoing.
REASON
Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.
VOLUME OF PRODUCT IN COMMERCE
56 boxes.
DISTRIBUTION
Nationwide, and Canada.

_______________________________
PRODUCT
ACCU-CHEK Inform meter; catalog No. 3035123. Recall Z-0372-05.
CODE
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp. Indianapolis, IN, a letter dated 11/19/04 Firm initiated recall is ongoing.
REASON
A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
VOLUME OF PRODUCT IN COMMERCE
4697.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05.
CODE
Software version 3.5.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letters dated November 12, 2004. Firm initiated recall is ongoing.
REASON
Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
IL, MD, NJ, OH, VA, Italy, Spain, and Portugal.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) BD, Brucella melitensis Antigen. Recall # Z-0311-05;
b) BD, Salmonella O Group D Antigen (9-12) (Typhoid O).
Recall # Z-0312-05;
c) BD, Salmonella Somatic Polyvalent Antiserum (A,B,D).
Recall # Z-0313-05;
d) BD, Brucella abortus Antigen. Recall # Z-0314-05;
e) BD, Salmonella Flagellar d Antigen (Typhoid H).
Recall # Z-0315-05;
f) BD, Salmonella O Group A Antigen (1-2-12).
Recall # Z-0316-05;
g) BD, Salmonella O Group B Antigen (1-4-5-12).
Recall # Z-0317-05;
h) BD, Salmonella Flagellar Polyvalent Antiserum
(a,b,d). Recall # Z-0318-05;
i) BD, Proteus OX19 Antigen. Recall # Z-0319-05;
j) BD, Francisella tularensis Antigen.
Recall # Z-0320-05;
k) BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19).
Recall # Z-0321-05;
l) BD, Brucella Postive Control Antiserum (AMS).
Recall # Z-0322-05;
m) BD, Febrile Antigen Negative Control.
Recall # Z-0323-05.
CODE
a) Catalogue #240943, Lot #3046337;
b) Catalogue #24074, Lot #2119981;
c) Catalogue #240941, Lot #3093814;
d) Catalogue #241049, Lot #2192837, 3029141,
2116596, 3029124 & 2092005;
e) Catalogue #240785, Lot #2192844 & Lot # 2270533;
f) Catalogue #240731, Lot #3072592, 3126311;
g) Catalogue #240732, Lot #3072597 & Lot #3121355;
h) Catalogue #240942, Lot #3029192;
i) Catalogue #240782, Lot #3035884;
j) Catalogue #241050, Lot #2289707,
2191842 & 166779;
k) Catalogue #240490, Lot #3079439;
l) Catalogue #240934, Lot #3210932;
m) Catalogue #240937, Lot #3093813.
RECALLING FIRM/MANUFACTURER
BD Diagnostic Systems, Grayson, GA, by letter beginning October 20, 2004. Firm initiated recall is ongoing.
REASON
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. The Antigen Dilution instructions incorrectly state to dilute "one part antigen in fifty parts 0.85% saline (1:50)". The correct instructions should read "one part antigen in forty-nine parts 0.85% saline (1:50)".
VOLUME OF PRODUCT IN COMMERCE
6,946 vials.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Immulite 2500 insulin Kit. Recall # Z-0324-05.
CODE
Lot 102A.
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp, Los Angeles, CA, by telephone on November 19, 2004. Firm initiated recall is ongoing.
REASON
Low bias of 10 to 40% at different levels of insulin in samples.
VOLUME OF PRODUCT IN COMMERCE
10 kits.
DISTRIBUTION
AK, NY, and WI.

_______________________________
PRODUCT
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade. The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase. Recall # Z-0325-05.
CODE
The kit lot number is 42003. The conjugate lot number is 42023.
RECALLING FIRM/MANUFACTURER
Diamedix Corporation, Miami, FL, by letter dated October 8, 2003. Firm initiated recall is ongoing.
REASON
Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
VOLUME OF PRODUCT IN COMMERCE
265 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2" wide; 16-1033-3-STR, 3" wide; 16-1033-4-STR, 4" wide; and 16-1033-6-STR, 6" wide. Recall # Z-0368-05.
CODE
Lot numbers 3001 through 40999.
RECALLING FIRM/MANUFACTURER
Cypress Medical Products, Ltd., McHenry, IL, by telephone and letter on December 1, and December 2, 2004. Firm initiated recall is ongoing.
REASON
The elastic bandages which are labeled sterile have a lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
17,964 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR January 12, 2005

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