Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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July 25, 2007
07-30

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Adeline’s Bacon, approximate wt 4 oz, Recall # F-443-7;
CODE
None
RECALLING FIRM/MANUFACTURER
Adelines, Inc., Nashville, TN, by telephone on May 11, 2007. Firm initiated recall is complete.
REASON
Product contained undeclared milk and wheat.
VOLUME OF PRODUCT IN COMMERCE
20 sandwiches
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
a) Adeline's Steak and Cheese, approx. wt 6 oz, Recall # F-441-7;
b) Adeline’s Steak, Egg and Cheese, approx. wt 7 oz, Recall # F-442-7;
c) Adeline’s Bacon, Egg and Cheese, approx. wt. 5.5 oz, Recall # F-444-7
CODE
None
RECALLING FIRM/MANUFACTURER
Adelines, Inc., Nashville, TN, by telephone on May 11, 2007. Firm initiated recall is complete.
REASON
Product contained undeclared milk and wheat. Cheese was listed on the label.
VOLUME OF PRODUCT IN COMMERCE
a) 10 sandwiches;
b) 2 sandwiches;
c) 63 sandwiches
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
Adult Multivitamins with Selenium, 1000 tablets/bottle; NDC #51376-0180-10, Recall # F-445-7
CODE
Lot #704064
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blessings International, Tulsa, OK, by e-mail on June 26, 2007.
Manufacturer: Rasi Laboratories, Inc., Somerset, NJ. Firm initiated recall is ongoing.
REASON
Product was mislabeled in that it contained iron and iodine, which were not listed.
VOLUME OF PRODUCT IN COMMERCE
188 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
H2O+ Aquafirm Retexturinzing Cleanser; a creamy, exfoliating lotion that helps dissolve make-up and remove dead surface skin cells while cleansing; 5.5 fl oz. turquoise plastic tube with a clear flip-cap, 6 tubes per shipper; UPC 7 64505 00145 9, Recall # F-446-7
CODE
Lot number 2006/03/17H05
RECALLING FIRM/MANUFACTURER
H2O Plus, L.P., Chicago, IL, by e-mail on October 6, 2006, December 29, 2006, January 15, 2007 and February 14, 2007. Firm initiated recall is complete.
REASON
The cleanser was found to be contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
3,759 tubes
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
AZMACORT (triamcinolone acetonide) Inhalation Aerosol - One 20g Inhaler - 240 Metered Actuations - Rx only, Recall # D-835-2007
CODE
Lot # BAA211 Expiration date: 08/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letters on May 3, 2007.
Manufacturer: INyX USA, Ltd., Manati, PR. Firm initiated recall is ongoing.
REASON
Presence of foreign substance.
VOLUME OF PRODUCT IN COMMERCE
2,184 packages
DISTRIBUTION
NV, NY and TN
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PRODUCT
Advil® Tablets (Ibuprofen), 200 mg, UPC 3-0573-0154-17-8, Recall # D-836-2007
CODE
B83369 Exp 08/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Consumer Healthcare, Madison, NJ, by telephone and fax, on March 14, 2007.
Manufacturer: Wyeth Pharmaceuticals Company, Guayama, PR. Firm initiated recall is complete.
REASON
Incorrect Expiration Date; product incorrectly labeled as "80/08" rather than correctly as "08/08".
VOLUME OF PRODUCT IN COMMERCE
360 cases. 2 count foil pouches/3000 pouches/case
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1296-07
CODE
Unit: 9336043 (Parts 1& 2)
RECALLING FIRM/MANUFACTURER
New York Blood Center, New York, NY, by telephone on May 14, 2004 and by follow-up letter dated May 14, 2004. Firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1297-07
CODE
Unit: 5840351
RECALLING FIRM/MANUFACTURER
New York Blood Center, New York, NY, by telephone on July 31, 2003 and by letter dated August 12, 2003. Firm initiated recall is complete.
REASON
Blood product, tested for viral markers using an unsuitable testing sample was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1330-07
CODE
Unit: 231542242
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone, on April 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled as irradiated but did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Human Cornea Tissue, Recall # B-1333-07
CODE
Units: 070085100, 070085200
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone, on April 11, 2007. Firm initiated recall is complete.
REASON
Human corneal tissues, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
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PRODUCT
Source Plasma, Recall # B-1339-07
CODE
Units: 06LFLA5908, 06LFLA6130, and 06LFLA3652
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Lakeland, FL, by fax on June 6, 2006. Firm initiated recall is complete.
REASON
Failure to quarantine unit due to medical history; Donor received tattoo.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and NY
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1346-07
CODE
Unit: 9975205 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 18, 2006 and letter on June 22, 2006. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit (2 parts)
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Source Plasma, Recall # B-1323-07
CODE
Units: 364006630, 364006317, 364014145, 364005616, 364004960, 364005092, 364010305, 364000724, 364010371, 364012995, 364009468, 364007302, 364006455, 364004249, 364010025, 364010439, 364007156, 364007492, 364011025, 364005950, 364014831, 364014036, 364006783, 364004844, 364012068, 364005459, 364004934, 364009897, 364004305, 364003154, 364012409, 364006573, 364004463, 364009378, 364005540, I72057150, I72060302, 364011280, 364011524, 364013523, 364010303, 364015274, 364011292, 364014898, 364005114, 364000416, 364006078, 364015348, 364007058, 364007094, 364004532, 364005211, 364011410, 364004366, 364004630, 364005484, 364007941, 364011903, 364015345, 364006124, 364006747, 364011427, 364011294, 364006443, 364015287, 364011601, 364006409, 364007379, 364005571, 364014023, 364015261, 364011542, 364007033, 364012332, 364015060, 364012540, 364012953, 364006304, 364015292, 364009842, 364006104, 364011467
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Ft. Worth, TX, by fax, on December 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Platelets Pooled, Recall # B-1326-07;
b) Platelets, Recall # B-1327-07;
c) Platelets Pooled Irradiated, Recall # B-1328-07
CODE
a) GR40896 (Pool # P25941), GR40943 (Pool # P25937), GR40962 (Pool # P25921),
GR40963 (Pool # P25918) GR40978 (Pool # P25942), GR40985 (Pool # P25929)
GR41001 (Pool # P25942), KC12056 (Pool # P25960);
b) LE54212;
c) FJ90012 (Pool # P25990)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on April 8, 2003. Firm initiated recall is complete.
REASON
Platelets, which were not prepared within the required time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

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PRODUCT
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007
CODE
Product codes 2M8153: Serial numbers 10070004CT, 10070015CT, 10070024CT, 10070035CT, 10070054CT, 10070072CT, 10070079CT, 10070107CT, 10070119CT, 10070125CT, 10070150CT, 10070166CT, 10070175CT, 10070177CT, 10070182CT, 10070185CT, 10070253CT, 10070266CT, 10070272CT, 10080018CT, 10080053CT, 10080064CT, 10080072CT, 10080084CT, 10080147CT, 10080171CT, 10080181CT, 10080215CT, 10080221CT, 10080226CT, 10080302CT, 10080419CT, 10080424CT, 10080469CT, 10080483CT, 10080503CT, 10080510CT, 10080511CT, 10080524CT, 10080571CT, 10080590CT, 10080615CT, 10080631CT, 10080637CT, 10082059CT, 10082114CT, 10082179CT, 10082183CT, 10082218CT, 10082224CT, 10082411CT, 10090025CT, 10090099CT, 10090115CT, 10090166CT, 10090201CT, 10090205CT, 10090211CT, 10090228CT, 10090235CT, 10090243CT, 10090283CT, 10090371CT, 10090421CT, 10090452CT, 10090466CT, 10090472CT, 10090482CT, 10090491CT, 10090494CT, 10090496CT, 10090545CT, 10090557CT, 10090587CT, 10090596CT, 10090609CT, 10090636CT, 10090639CT, 10090644CT, 10090647CT, 10091362CT, 10100058CT, 10100095CT, 10100171CT, 10105027CT, 10105094CT, 10105144CT, 10105145CT, 10105163CT, 10105375CT, 10105411CT, 10105581CT, 10105643CT, 10105754CT, 10105890CT, 10106140CT, 10106167CT, 10106168CT, 10106206CT, 10106215CT, 10106217CT, 10106561CT, 10115040CT, 10115153CT, 10115363CT, 10115379CT, 10115408CT, 10115409CT, 10115468CT, 10115528CT, 10120023CT, 10120047CT, 10120115CT, 10120133CT, 10120143CT, 10120145CT, 10120153CT, 10120156CT, 10120164CT, 10120170CT, 10120172CT, 10120192CT, 10120205CT, 10120239CT, 10120248CT, 10120270CT, 10120272CT, 10120283CT, 10120284CT, 10120298CT, 10120300CT, 10120397CT, 11010218CT, 11010252CT, 11010287CT, 11010364CT, 11010372CT, 11010384CT, 11010389CT, 11010410CT, 11010419CT, 11010421CT, 11010437CT, 11010447CT, 11010449CT, 11010453CT, 11010455CT, 11010458CT, 11020042CT, 11020096CT, 11020150CT, 11020241CT, 11020421CT, 11020503CT, 11020504CT, 11020635CT, 11020646CT, 11020649CT, 11020816CT, 11021004CT, 11021011CT, 11021013CT, 11030457CT, 11040049CT, 11040199CT, 11040208CT, 11040233CT, 11040297CT, 11040373CT, 11040386CT, 11040442CT, 11040488CT, 11040510CT, 11040518CT, 11040585CT, 11040614CT, 11040646CT, 11040722CT, 11040771CT, 11040786CT, 11040840CT, 11040862CT, 11040885CT, 11040900CT, 11040930CT, 11040977CT, 11040987CT, 11041018CT, 11050013CT, 11050014CT, 11050021CT, 11050024CT, 11050034CT, 11050057CT, 11050059CT, 11050060CT, 11050061CT, 11050063CT, 11050066CT, 11050070CT, 11050084CT, 11050093CT, 11050096CT, 11050097CT, 11050114CT, 11050117CT, 11050122CT, 11050127CT, 11050129CT, 11050140CT, 11050164CT, 11050175CT, 11050233CT, 11050238CT, 11050255CT, 11050266CT, 11051040CT, 11051098CT, 11051113CT, 11051132CT, 11060065CT, 11060070CT, 11060084CT, 11060141CT, 11060184CT, 11060195CT, 11070046CT, 11070081CT, 11070186CT, 11070215CT, 11070227CT, 11070238CT, 11070295CT, 11070390CT, 11070392CT, 11070412CT, 11070426CT, 11070430CT, 11070502CT, 11070518CT, 11070543CT, 11070550CT, 11070643CT, 11080045CT, 11080081CT, 11080183CT, 11080395CT, 11080404CT, 11080415CT, 11080465CT, 11080483CT, 11080625CT, 11080635CT, 11080733CT, 11080740CT, 11080755CT, 11080767CT, 11080770CT, 11080821CT, 11080870CT, 11080988CT, 11080991CT, 11081014CT, 11081085CT, 11081093CT, 11081109CT, 11081117CT, 11081129CT, 11081130CT, 11081173CT, 11081185CT, 11081187CT, 11081201CT, 11081214CT, 11081224CT, 11090009CT, 11090015CT, 11090047CT, 11090049CT, 11090052CT, 11090064CT, 11090069CT, 11090078CT, 11090110CT, 11090111CT, 11090134CT, 11090136CT, 11090144CT, 11090163CT, 11090180CT, 11090186CT, 11090189CT, 11090202CT, 11090209CT, 11090211CT, 11090212CT, 11090232CT, 11090237CT, 11090523CT, 11090555CT, 11090731CT, 11090764CT, 11090777CT, 11090784CT, 11090788CT, 11090815CT, 11090853CT, 11090870CT, 11090871CT, 11090882CT, 11090921CT, 11090889CT, 11090938CT, 11090943CT, 11090947CT, 11090952CT, 11090967CT, 11090968CT, 11090990CT, 11090995CT, 11090996CT, 11091005CT, 11091020CT, 11091029CT, 11091030CT, 11100058CT, 11100064CT, 11100117CT, 11100178CT, 11100280CT, 11100439CT, 11100463CT, 11100549CT, 11100558CT, 11100590CT, 11100605CT, 11100612CT, 11100635CT, 11100680CT, 11100689CT, 11100703CT, 11100714CT, 11100724CT, 11100748CT, 11100750CT, 11100754CT, 11100782CT, 11100817CT, 11100961CT, 11100979CT, 11100982CT, 11100986CT, 11100991CT, 11100994CT, 11100997CT, 11101011CT, 11101052CT, 11101083CT, 11101090CT, 11101134CT, 11101154CT, 11101274CT, 11101283CT, 11101292CT, 11101303CT, 11101318CT, 11101331CT, 11101363CT, 11101463CT, 11101475CT, 11101485CT, 11101508CT, 11101532CT, 11101537CT, 11101630CT, 11101653CT, 11101657CT, 11110053CT, 11110093CT, 11110110CT, 11110118CT, 11110156CT, 11110163CT, 11110165CT, 11110233CT, 11110404CT, 11110482CT, 11110563CT, 11120003CT, 11120005CT, 11120006CT, 11120007CT, 12010117CT, 12010189CT, 12010214CT, 12010378CT, 12010385CT, 12010417CT, 12010500CT, 12010503CT, 12010547CT, 12020034CT, 12020071CT, 12020082CT, 12020094CT, 12020115CT, 12020122CT, 12020153CT, 12020157CT, 12020196CT, 12030002CT, 12030121CT, 12030150CT, 12030215CT, 12030393CT, 12030395CT, 12030457CT, 12030495CT, 12040104CT, 12040170CT, 12040192CT, 12050077CT, 12050080CT, 12050105CT, 12060004CT, 12060042CT, 12060086CT, 12060099CT, 12060122CT, 12060126CT, 12060162CT, 12060234CT, 12060237CT, 12070123CT, 12070198CT, 12070223CT, 12070258CT, 12070262CT, 12080054CT, 12080060CT, 12080075CT, 12080093CT, 12080096CT, 12080113CT, 12080123CT, 12080128CT, 12080135CT, 12080144CT, 12080176CT, 12080259CT, 12090042CT, 12090055CT, 12090101CT, 12090132CT, 12090159CT, 12090179CT, 12090198CT, 12090209CT, 12090227CT, 12090267CT, 12090284CT, 12090299CT, 12090304CT, 12090349CT, 12090352CT, 12090391CT, 12090519CT, 12100013CT, 12100031CT, 12100181CT, 12100189CT, 12100190CT, 12100203CT, 12100220CT, 12100244CT, 12100295CT, 12100307CT, 12100324CT, 12100337CT, 12100409CT, 12100414CT, 12100500CT, 12100509CT, 12110001CT, 12110037CT, 12110080CT, 12110087CT, 12110088CT, 12110121CT, 12110142CT, 12110201CT, 12110280CT, 12110369CT, 12120036CT, 12120039CT, 12120059CT, 12120185CT, 12120195CT, 12120214CT, 12120222CT, 12120229CT, 12120239CT, 12120249CT, 12120254CT, 12120264CT, 12120299CT, 13030048CT, 13030095CT, 13030116CT, 13030122CT, 13030131CT, 13030178CT, 13030194CT, 13030210CT, 13060018CT, 13060063CT, 13070032CT, 13070048CT, 13070120CT, 13070160CT, 13070185CT, 13110027CT, 13110051CT, 14020070CT, 14020170CT, 14020205CT, 14030005CT, 14030091CT, 14030116CT, 14030122CT, 14030135CT, 14040006CT, 14040009CT, 14040011CT, 14040013CT, 14040021CT, 14040022CT, 14040023CT, 14040048CT, 14060168CT, 14100037CT, 15040031CT, RA01562CT;
Product code 2M8163: Serial numbers 11040028TC, 11060001TC, 11060020TC, 11060038TC, 11060074TC, 11060076TC, 11060083TC, 11060085TC, 11060106TC, 11060144TC, 11060152TC, 11060166TC, 11060224TC, 11060242TC, 11110002TC, 11110010TC, 11110012TC, 11110013TC, 11110014TC, 11110020TC, 11110024TC, 11110026TC, 11110029TC, 11110031TC, 11110035TC, 11110038TC, 11110039TC, 11110041TC, 11110043TC, 11110045TC, 11110048TC, 11110049TC, 11110052TC, 11110056TC, 11110057TC, 11110058TC, 11110060TC, 11110064TC, 11110065TC, 11110068TC, 11110072TC, 11110075TC, 11110080TC, 11110081TC, 11110083TC, 11110085TC, 11110089TC, 11110090TC, 11110105TC, 11110109TC, 11110110TC, 11110113TC, 11110129TC, 11110132TC, 11110139TC, 11110140TC, 11110142TC, 11110143TC, 11110147TC, 11110148TC, 11110150TC, 11110152TC, 11110155TC, 11110157TC, 11110168TC, 11110173TC, 11110174TC, 11110180TC, 11110183TC, 11110184TC, 11110193TC, 11110198TC, 11110202TC, 11110203TC, 11110206TC, 11110210TC, 11110217TC, 11110221TC, 11110228TC, 11110239TC, 11110250TC, 11110263TC, 11110269TC, 11110272TC, 11110276TC, 11110280TC, 11110285TC, 11110287TC, 11110293TC, 11110337TC, 11110346TC, 11110350TC, 11110358TC, 11110365TC, 11110368TC, 11110378TC, 11110413TC, 11110493TC, 11110504TC, 11110515TC, 11110549TC, 11110553TC, 11110598TC, 11110612TC, 11110706TC, 11110722TC, 11110809TC, 11110828TC, 11110854TC, 11110880TC, 11120030TC, 11120045TC, 11120049TC, 11120054TC, 11120070TC, 11120106TC, 11120121TC, 11120176TC, 11120221TC, 11120248TC, 11120262TC, 11120355TC, 11120392TC, 11120431TC, 11120441TC, 11120454TC, 11120469TC, 11120475TC, 11120483TC, 11120498TC, 11120518TC, 11120530TC, 11120565TC, 11120566TC, 11120600TC, 11120612TC, 11120638TC, 11120674TC, 11120685TC, 12010080TC, 12010105TC, 12010126TC, 12010170TC, 12010189TC, 12010206TC, 12010241TC, 12010244TC, 12010285TC, 12010339TC, 12010344TC, 12010367TC, 12010381TC, 12010382TC, 12010384TC, 12010416TC, 12010424TC, 12010432TC, 12030032TC, 12030037TC, 12030089TC, 12030106TC, 12030148TC, 12030193TC, 12030199TC, 12030204TC, 12040007TC, 12040053TC, 12040064TC, 12040095TC, 12040153TC, 12040186TC, 12040213TC, 12040220TC, 12040349TC, 12040439TC, 12050034TC, 12050044TC, 12050075TC, 12050085TC, 12050094TC, 12050103TC, 12050164TC, 12050197TC, 12050201TC, 12050223TC, 12050237TC, 12050246TC, 12050306TC, 12050333TC, 12050351TC, 12050356TC, 12050365TC, 12050390TC, 12050393TC, 12050395TC, 12050409TC, 12050426TC, 12050451TC, 12050487TC, 12050492TC, 12050494TC, 12050613TC, 12050619TC, 12050636TC, 12050671TC, 12050699TC, 12050764TC, 12050773TC, 12050798TC, 12060037TC, 12060038TC, 12060052TC, 12060071TC, 12060081TC, 12060087TC, 12060103TC, 12060115TC, 12060116TC, 12060124TC, 12060126TC, 12060130TC, 12060154TC, 12060161TC, 12060175TC, 12060179TC, 12060186TC, 12060187TC, 12060192TC, 12060193TC, 12060194TC, 12060253TC, 12060262TC, 12060277TC, 12060294TC, 12060298TC, 12060299TC, 12060301TC, 12060315TC, 12060316TC, 12060323TC, 12060325TC, 12060330TC, 12060332TC, 12060335TC, 12060338TC, 12060340TC, 12060353TC, 12060375TC, 12060380TC, 12060393TC, 12060404TC, 12060409TC, 12060417TC, 12060431TC, 12060433TC, 12060436TC, 12060441TC, 12060451TC, 12060475TC, 12060489TC, 12060494TC, 12060496TC, 12060504TC, 12060511TC, 12060522TC, 12060523TC, 12060528TC, 12060529TC, 12060253TC, 12060262TC, 12060277TC, 12060294TC, 12060298TC, 12060299TC, 12060301TC, 12060315TC, 12060316TC, 12060323TC, 12060325TC, 12060330TC, 12060332TC, 12060335TC, 12060338TC, 12060340TC, 12060353TC, 12060375TC, 12060380TC, 12060393TC, 12060404TC, 12060409TC, 12060417TC, 12060431TC, 12060433TC, 12060436TC, 12060441TC, 12060451TC, 12060475TC, 12060489TC, 12060494TC, 12060496TC, 12060504TC, 12060511TC, 12060522TC, 12060523TC, 12060528TC, 12060529TC, 12060535TC, 12060549TC, 12060601TC, 12060627TC, 12060629TC, 12060641TC, 12060657TC, 12060664TC, 12060682TC, 12060691TC, 12060692TC, 12060702TC, 12060704TC, 12060711TC, 12060720TC, 12060745TC, 12070020TC, 12070023TC, 12070030TC, 12070036TC, 12070037TC, 12070046TC, 12070049TC, 12070055TC, 12070069TC, 12070073TC, 12070094TC, 12070096TC, 12070101TC, 12070102TC, 12070105TC, 12070106TC, 12070108TC, 12070112TC, 12070124TC, 12070135TC, 12070140TC, 12070152TC, 12070171TC, 12070176TC, 12070215TC, 12070228TC, 12070239TC, 12070353TC, 12070368TC, 12070454TC, 12070479TC, 12070493TC, 12070609TC, 12070628TC, 12070674TC, 12070707TC, 12070716TC, 12070740TC, 12070745TC, 12070759TC, 12070761TC, 12070773TC, 12070777TC, 12070783TC, 12070796TC, 12070797TC, 12080012TC, 12080027TC, 12080036TC, 12080040TC, 12080092TC, 12080116TC, 12080124TC, 12080179TC, 12080187TC, 12080199TC, 12080233TC, 12080306TC, 12080347TC, 12080400TC, 12080499TC, 12080521TC, 12080527TC, 12080530TC, 12080549TC, 12080564TC, 12080568TC,,12080572TC, 12080593TC, 12080609TC, 12080614TC, 12080618TC, 12080649TC, 12080677TC, 12080683TC, 12080702TC, 12080709TC, 12080839TC, 12080863TC, 12080867TC, 12080873TC, 12090043TC, 12090044TC, 12090101TC, 12090167TC, 12090217TC, 12090230TC, 12090249TC, 12090325TC, 12090426TC, 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15080303TC, 15080304TC, 15080305TC, 15080307TC, 15080308TC, 15080310TC, 15080312TC, 15080313TC, 15080314TC, 15080315TC, 15080316TC, 15080317TC, 15080318TC, 15080319TC, 15080321TC, 15080322TC, 15080324TC, 15080325TC, 15080327TC, 15080329TC, 15080330TC, 15080331TC, 15080332TC, 15080334TC, 15080338TC, 15080339TC, 15080340TC, 15080341TC, 15080342TC, 15080343TC, 15080344TC, 15080345TC, 15080348TC, 15080350TC, 15080352TC, 15080353TC, 15080354TC, 15080355TC, 15080356TC, 15080358TC, 15080359TC, 15080361TC, 15080362TC, 15080363TC, 15080364TC, 15080365TC, 15080366TC, 15080367TC, 15080370TC, 15080371TC, 15080372TC, 15080373TC, 15080375TC, 15080376TC, 15080377TC, 15080379TC, 15080380TC, 15080381TC, 15080382TC, 15080383TC, 15080384TC, 15080385TC, 15080387TC, 15080388TC, 15080390TC, 15080391TC, 15080392TC, 15080393TC, 15080395TC, 15080397TC, 15080399TC, 15080400TC, 15080401TC, 15080402TC, 15080403TC, 15080404TC, 15080405TC, 15080406TC, 15080409TC, 15080410TC, 15080411TC, 15080412TC, 15080413TC, 15080414TC, 15080416TC, 15080417TC, 15080418TC, 15080420TC, 15080421TC, 15080422TC, 15080423TC, 15080424TC, 15080425TC, 15080426TC, 15080427TC, 15080429TC, 15080430TC, 15080431TC, 15080432TC, 15080433TC, 15080434TC, 15080435TC, 15080437TC, 15080439TC, 15080440TC, 15080441TC, 15080442TC, 15080443TC, 15080444TC, 15080445TC, 15080446TC, 15080447TC, 15080448TC, 15080449TC, 15080450TC, 15080452TC, 15080453TC, 15080454TC, 15080455TC, 15080456TC, 15080457TC, 15080458TC, 15080459TC, 15080464TC, 15080465TC, 15080467TC, 15080468TC, 15080469TC, 15080470TC, 15080471TC, 15080472TC, 15080474TC, 15080475TC, 15080476TC, 15080477TC, 15080478TC, 15080479TC, 15080482TC, 15080483TC, 15080484TC, 15080485TC, 15080486TC, 15080487TC, 15080488TC, 15080489TC, 15080490TC, 15080491TC, 15080492TC, 15080493TC, 15080494TC, 15080496TC, 15080497TC, 15080498TC, 15080499TC, 15080501TC, 15080502TC, 15080503TC, 15080505TC, 15080506TC, 15080602TC, 15080607TC ,15080616TC , 15080625TC, 15080626TC, 15080628TC, 15080637TC, 15080643TC, 15080644TC, 15080653TC, 15080657TC, 15080660TC, 15080663TC, 15080668TC, 15080671TC, 15080672TC, 15080674TC, 15080684TC, 15080686TC, 15080688TC, 15080690TC, 15080691TC, 15080702TC, 15080705TC, 15080707TC, 15080718TC, 15080722TC, 15080726TC, 15080735TC, 15080736TC, 15080737TC, 15080744TC, 15080753TC, 15080755TC, 15080756TC, 15080782TC, 15080797TC, 15080799TC, 15080821TC, 15080831TC, 15080834TC, 15080865TC, 15080884TC, 15080887TC, 15080889TC, 15080890TC, 15080894TC, 15080897TC, 15080905TC, 15080913TC, 15080919TC, 15080921TC, 15080932TC, 15080934TC, 15080937TC, 15080940TC, 15080942TC, 15080945TC, 15080949TC, 15080950TC, 15080958TC, 15080967TC, 15080972TC, 15080981TC, 15080982TC, 15080997TC, 15081010TC, 15081012TC, 15081015TC, 15081017TC, 15081022TC, 15081032TC, 15081036TC, 15081067TC, 15081082TC, 15081085TC, 15081087TC, 15081093TC, 15081101TC, 15081106TC, 15081120TC, 15081124TC, 15081155TC, 15081159TC, 15081160TC, 15081173TC, 15081188TC, 15081189TC, 15081211TC, 15081217TC, 15081220TC, 15081255TC, 15081263TC, 15081267TC, 15081281TC, 15081288TC, 15081293TC, 15081298TC, 15081302TC, 15081336TC, 15081400TC, 15081404TC, 15081407TC, 15081429TC, 15081434TC, 15081442TC, 15081479TC, 15081484TC, 15081493TC, 15081517TC, 15081522TC, 15081526TC, 15081542TC, 15081569TC, 15081578TC, 15081586TC, 15081595TC, 15081610TC, 15081611TC, 15081612TC, 15081627TC, 15090605TC, 15090612TC, 15090613TC, 15090615TC, 15090616TC, 15090623TC, 15090626TC, 15090628TC, 15090632TC, 15090636TC, 15090638TC, 15090646TC, 15090647TC, 15090650TC, 15090653TC, 15090655TC, 15090657TC, 15090659TC, 15090661TC, 15090664TC, 15090665TC, 15090667TC, 15090669TC, 15090672TC, 15090674TC, 15090676TC, 15090677TC, 15090678TC, 15090681TC, 15090691TC, 15090695TC, 15090696TC, 15090697TC, 15090698TC, 15090699TC, 15090701TC, 15090702TC, 15090705TC, 15090716TC, 15090717TC, 15090721TC, 15090723TC, 15090724TC, 15090727TC, 15090730TC, 15090731TC, 15090734TC, 15090738TC, 15090739TC, 15090741TC, 15090742TC, 15090744TC, 15090745TC, 15090746TC, 15090747TC, 15090751TC, 15090752TC, 15090754TC, 15090755TC, 15090756TC, 15090758TC, 15090759TC, 15090765TC, 15090766TC, 15090769TC, 15090772TC, 15100483TC, 15100492TC, 15100493TC, 15100496TC, 15100502TC, 15100505TC, 15100513TC, 15100519TC, 15100522TC, 15100536TC, 15100542TC, 15100546TC, 15100548TC, 15100549TC, 15100558TC, 15100559TC, 15100565TC, 15100566TC, 17040008TC, 17040013TC, 17040016TC, 17040019TC, 17040025TC, 17040043TC, 17040046TC, 17040047TC, 17040058TC, 17040063TC, 17040068TC, 17040087TC, 17040095TC, 17040151TC, 17040153TC, 17040157TC, 17040158TC, 17040181TC, 17050277TC, 17050312TC, 17050326TC, 17050382TC, 17050389TC, RA01554TC;
Product code 2M9163: Serial numbers 17010002TP, 17010003TP, 17010004TP, 17010005TP, 17010006TP, 17010007TP, 17010008TP, 17010011TP, 17010015TP, 17010016TP, 17010018TP, 17010019TP, 17010020TP, 17010021TP, 17010022TP, 17010023TP, 17010024TP, 17010025TP, 17010031TP, 17010032TP, 17010033TP, 17010034TP, 17010035TP, 17010036TP, 17010037TP, 17010038TP, 17010039TP, 17010040TP, 17010041TP, 17010042TP, 17010043TP, 17010044TP, 17010045TP, 17010046TP, 17010047TP, 17010048TP, 17010049TP, 17010050TP, 17010051TP, 17010052TP, 17010053TP, 17010054TP, 17010055TP, 17010061TP, 17010062TP, 17010063TP, 17010064TP, 17010065TP, 17010066TP, 17010067TP, 17010068TP, 17010069TP, 17010070TP, 17010071TP, 17010072TP, 17010073TP, 17010074TP, 17010075TP, 17010076TP, 17010077TP, 17010078TP, 17010079TP, 17010080TP, 17010081TP, 17010082TP, 17010083TP, 17010084TP, 17010085TP, 17040001TP, 17040002TP, 17040003TP, 17040004TP, 17040005TP, 17040006TP, 17040007TP, 17040008TP, 17040009TP, 17040010TP, 17040011TP, 17040012TP, 17040013TP, 17040014TP, 17040015TP, 17040016TP, 17040017TP, 17040018TP, 17040019TP, 17040020TP, 17040021TP, 17040022TP, 17040023TP, 17040024TP, 17040025TP, 17040026TP, 17040027TP, 17040028TP, 17040029TP, 17040030TP, 17040031TP, 17040032TP, 17040033TP, 17040034TP, 17040035TP, 17040036TP, 17040037TP, 17040038TP, 17040039TP, 17040040TP, 17040041TP, 17040042TP, 17040043TP, 17040044TP, 17040045TP, 17040046TP, 17040047TP, 17040048TP, 17040049TP, 17040051TP, 17040052TP, 17040053TP, 17040054TP, 17040055TP, 17040056TP, 17040057TP, 17040058TP, 17040059TP, 17040060TP, 17040061TP, 17040062TP, 17040064TP, 17040065TP, 17040066TP, 17040068TP, 17040069TP, 17040070TP, 17040071TP, 17040072TP, 17040073TP, 17040074TP, 17040075TP, 17040076TP, 17040077TP, 17040078TP, 17040079TP, 17040080TP, 17040081TP, 17040082TP, 17040083TP, 17040084TP, 17040085TP, 17040086TP, 17040087TP, 17040088TP, 17040089TP, 17040090TP, 17040091TP, 17040092TP, 17040093TP, 17040094TP, 17040095TP, 17040096TP, 17040097TP, 17040098TP, 17040099TP, 17040100TP, 17040101TP, 17040102TP, 17040103TP, 17040104TP, 17040106TP, 17040107TP, 17040108TP, 17040109TP, 17040110TP, 17040111TP, 17040112TP, 17040113TP, 17040114TP, 17040115TP, 17040116TP, 17040117TP, 17040118TP, 17040119TP, 17040120TP, 17040121TP, 17040122TP, 17040123TP, 17040124TP, 17040125TP, 17040126TP, 17040127TP, 17040128TP, 17040129TP, 17040130TP, 17040131TP, 17040132TP, 17040133TP, 17040134TP, 17040135TP, 17040136TP, 17040137TP, 17040138TP, 17040139TP, 17040140TP, 17040141TP, 17040142TP, 17040143TP, 17040144TP, 17040145TP, 17040146TP, 17040147TP, 17040148TP, 17040149TP, 17040150TP, 17040151TP, 17040152TP, 17040153TP, 17040154TP, 17040155TP, 17040156TP, 17040157TP, 17040158TP, 17040159TP, 17040160TP, 17040161TP, 17040162TP, 17040163TP, 17040164TP, 17040165TP, 17040166TP, 17040167TP, 17040168TP, 17040169TP, 17040170TP, 17040171TP, 17040172TP, 17040173TP, 17040174TP, 17040175TP, 17040176TP, 17040177TP, 17040178TP, 17040179TP, 17040180TP, 17040181TP, 17040217TP, 17040218TP, 17040219TP, 17040220TP, 17040221TP, 17040222TP, 17040223TP, 17040224TP, 17040225TP, 17040226TP, 17040227TP, 17040228TP, 17040229TP, 17040230TP, 17040231TP, 17040232TP, 17040233TP, 17040234TP, 17040235TP, 17040236TP, 17040237TP, 17040238TP, 17040239TP, 17040240TP, 17040241TP, 17040242TP, 17040243TP, 17040244TP, 17040245TP, 17040246TP, 17040247TP, 17040248TP, 17040249TP, 17040250TP, 17040251TP, 17040252TP, 17040253TP, 17040254TP, 17040255TP, 17040257TP, 17040258TP, 17040259TP, 17040260TP, 17040261TP, 17040262TP, 17040263TP, 17040264TP, 17040265TP, 17040266TP, 17040267TP, 17040268TP, 17040269TP, 17040270TP, 17040271TP, 17040272TP, 17040273TP, 17040274TP, 17040275TP, 17040276TP, 17040277TP, 17040278TP, 17040279TP, 17040280TP, 17040281TP, 17040282TP, 17040283TP, 17040284TP, 17040285TP, 17040286TP, 17040287TP, 17040288TP, 17040289TP, 17040290TP, 17040291TP, 17040292TP, 17040293TP, 17040294TP, 17040295TP, 17040296TP, 17040297TP, 17040298TP, 17040299TP, 17040300TP, 17040301TP, 17040302TP, 17040303TP, 17040304TP, 17040305TP, 17040306TP, 17040307TP, 17040308TP, 17040309TP, 17040310TP, 17040311TP, 17040312TP, 17040313TP, 17040314TP, 17040315TP, 17040316TP, 17040317TP, 17040318TP, 17040319TP, 17040320TP, 17040321TP, 17040322TP, 17040323TP, 17040324TP, 17040325TP, 17040326TP, 17040327TP, 17040328TP, 17040329TP, 17040330TP, 17040331TP, 17040332TP, 17040333TP, 17040334TP, 17040335TP, 17040336TP, 17040337TP, 17050006TP, 17050009TP, 17050011TP, 17050013TP, 17050017TP, 17050022TP, 17050025TP, 17050026TP, 17050034TP, 17050038TP, 17050044TP, 17050054TP, 17050065TP, 17050072TP, 17050076TP, 17050086TP, 17050094TP, 17050097TP, 17050100TP, 17050104TP, 17050113TP, 17050128TP, 17050129TP, 17050130TP, 17050145TP, 17050146TP, 17050148TP, 17050159TP, 17050161TP, 17050166TP, 17050171TP, 17050172TP, 17050174TP, 17050179TP, 17050181TP, 17050182TP, 17050433TP, 17050434TP, 17050435TP, 17050437TP, 17050438TP, 17050439TP, 17050442TP, 17050443TP, 17050444TP, 17050445TP, 17050447TP, 17050448TP, 17050449TP, 17050451TP, 17050452TP, 17050453TP, 17050454TP, 17050455TP, 17050456TP, 17050457TP, 17050459TP, 17050460TP, 17050461TP, 17050462TP, 17050463TP, 17050464TP, 17050465TP, 17050466TP, 17050469TP, 17050471TP, 17050473TP, 17050474TP, 17050478TP, 17050479TP, 17050480TP, 17050481TP, 17050482TP, 17050483TP, 17050484TP, 17050485TP, 17050486TP, 17050487TP, 17050488TP, 17050489TP, 17050490TP, 17050491TP, 17050492TP, 17050493TP, 17050494TP, 17050496TP, 17050497TP, 17050499TP, 17050500TP, 17050501TP, 17050502TP, 17050503TP, 17050504TP, 17050505TP, 17050506TP, 17050507TP, 17050508TP, 17050509TP, 17050511TP, 17050513TP, 17050514TP, 17050515TP, 17050516TP, 17050517TP, 17050518TP, 17050519TP, 17050520TP, 17050522TP, 17050524TP, 17050525TP, 17050526TP, 17050527TP, 17050528TP, 17050529TP, 17050530TP, 17050531TP, 17050532TP, 17050534TP, 17050535TP, 17050536TP, 17050537TP, 17050540TP, 17050545TP, 17050546TP, 17050548TP, 17050549TP, 17050550TP, 17050552TP, 17050553TP, 17050554TP, 17050557TP, 17050558TP, 17050559TP, 17050562TP, 17050591TP, 17050598TP, 17050601TP, 17050602TP, 17050605TP, 17050607TP, 17050608TP, 17050609TP, 17050613TP, 17050614TP, 17050615TP, 17050617TP, 17050619TP, 17050620TP, 17050621TP, 17050628TP, 17050629TP, 17050633TP, 17050636TP, 17050638TP, 17050641TP, 17050645TP, 17050646TP, 17050653TP, 17050655TP, 17050656TP, 17050661TP, 17050662TP, 17050672TP, 17050679TP, 17050683TP, 17050686TP, 17050700TP, 17050706TP, 17050707TP, 17050710TP, 17050712TP, 17050715TP, 17050718TP, 17050719TP, 17050722TP, 17050723TP, 17050724TP, 17050726TP, 17050730TP, 17050731TP, 17050739TP, 17050742TP, 17050743TP, 17050747TP, 17050748TP, 17050751TP, 17050755TP, 17050763TP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 20-21, 2007 and by letters dated June 22, 2007.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.
VOLUME OF PRODUCT IN COMMERCE
4,512 pumps
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X;

Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS

MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 oz.),
90105 (MoisturePLUS, 2 X 12 oz),
90106 (Complete MoisturePLUS Lens Comfort Pack),
90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case),
90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY),
90170 (Complete MoisturePLUS, 4 oz + Lens Case),
93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case),
93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO),
93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO),
93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO),
93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174),
93221 (Complete MoisturePLUS, 12 oz + Blink Sample),
93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case),
93341 (Complete MoisturePLUS, 4 oz);

The same formula (9451X) was sold in (1)Canada (Product Numbers:90113EC,

90175QW, 90176EC, 90177EC, 90187EC & 90197EC),
(2)Europe (Product Numbers: 90086DF, 90086FC, 90086SA, 90089AX, 90089FP,
90089GB, 90089NR, 90090EQ, 90090GM, 90090RR, 90090RY, 90091EG, 90091GB,
90091GM, 90091KZ, 90091NR, 90091RH, 9009SA, 90096AX, 90096EJ, 90096EQ,
90096EW, 90096FL, 90096FP, 90096GB, 90096GM, 90096LM, 90096RW, 90096RY,
90096SA, 90109FM, 90110EW, 90110FC, 90110FL, 90110KK, 90110KKD, 90115AX,
90115EW, 90115FP, 90115GB, 90115GM, 90115KH, 90117FP, 90117RH, 90118RR,
90119GM, 90119RH, 90124XQ, 90157KK, 90157KKD, 93099EQ, 93099RW, 93136LM,
93137LM, 93365GB & 93365NR),
(3)China (Product Numbers: 90281CH, 90282CH, 90283CH, 93095CH, 93191CH,
93262CH, 93283CH, 93404CH, 93407CH, 93416CH & 93464CH) &
(4)Various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea,
Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines)
under Product Numbers: 90104, 90190ED, 90192ED, 90193ED, 90194ED, 90195ED, 90228ED,
90281AS, 90281KO, 90282AS, 90282KO, 90283AS, 90283KO, 90283UT, 93126AS, 93126KO,
93126UT, 93233UT, 93262AS, 93375AS, 93376AS, 93377AS, 93378AS, 93378AS, 93379AS
& 93447AS, Recall # Z-1092-2007;
b) COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X,
    Product Numbers: 93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA,
    93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA,
    Recall # Z-1093-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by press release on May 25 and 26, 2007.
Manufacturer: Advanced Medical Optics Manufacturing Spain, S.L., Alcobendas (Madrid), Spain. Firm initiated recall is ongoing.
REASON
In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.
VOLUME OF PRODUCT IN COMMERCE
57,252,581 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
a) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek®,
    TOPS ASSY P/P SLING, Catalog #84414323, Recall # Z-1011-2007;
b) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture:
    Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2,
    Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2,
    Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2,
    Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,
   Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213,
   Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Recall # Z-1012-2007;
c) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture—
    Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,
    Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP,
    Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP,
    Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P,
    Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,
    Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P,
    Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P,
    Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,
    Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P,
    Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P,
    Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P,
    Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P,
    Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP,
    Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Recall # Z-1013-2007;
d) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures –
    Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N,
    Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN,
    Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N,
    Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N, Recall # Z-1014-2007;
e) Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-
    SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2;
    SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6,
    SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,
    SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7,
    SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2,
    SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6,
    SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,
    SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B,
    SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235,
    SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399, Recall # Z-1015-2007;
f) Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical
    Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137,
    Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Recall # Z-1016-2007;
g) Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester,
    TEV GN BR 0 TC-43/HR 262N, Catalog #833-114, Recall # Z-1017-2007;
h) Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48,
    Catalog #833-123, Recall # Z-1018-2007;
i) Various Sizes of Sterile Plyglycolic Acid Synthetic Surgical Suture-NDR,
    POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135, Recall # Z-1019-2007;
CODE
a) Lot #: 9591;
b) Lot #: 3244075; Lot #: 2361002; Lot #’s: 2401863 & 2498856;
    Lot #’s: 2443985 & 3080258; Lot #’s: 2528539, & 3163971; Lot # 2554480;
c) Lot #: 3328445; Lot #’s: 3313774 & 3200044; Lot #’s: 2297080 & 2467234;
    Lot #: 2486461; Lot #: 2351154; Lot #: 2351154; Lot #’s: 2306894 & 3308136;
    Lot #: 2324039; Lot #’s: 2262121 & 2306894; Lot #: 2306897; Lot #’s: 3211901 & 3346174;
    Lot #’s: 2306899 & 2306900; Lot #: 3335219; Lot #: 3335220;
d) Lot #: 2535750; Lot #: 2297631; Lot #’s: 2396240, 2498757 & 2511511;
e) Lot #: 105821; Lot #: 80513; Lot #: 1015798; Lot #: 67227; Lot #: 67228; Lot #: 39238;
    Lot #: 8727; Lot #: 72507;
f) Lot #’s: 2503061, 2503063, 2761528, 2761529, 2694983, 3152877, 3169994, 2395967,
    3163970 & 3232258; Lot #’s: 2360982 & 2381287;
g) Lot #’s: 21486, 21487, 21488, 23468, 23469, 41910 & 55380;
h) Lot #: 35089;
i) Lot #: 2721010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Creek Dr, Durham, NC, by letter, telephone, e-mail or fax on June 7, 2007.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
VOLUME OF PRODUCT IN COMMERCE
1,920 units
DISTRIBUTION
CO, FL, IL, IN, MA, OH, Canada, France and Germany

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

__________________________________
PRODUCT
TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution, Recall # Z-1056-2007
CODE
Lot Number: 45050Q100
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on March 20, 2007. Firm initiated recall is ongoing.
REASON
Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.
VOLUME OF PRODUCT IN COMMERCE
1,005 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

__________________________________
PRODUCT
Dry rendered tankage (DRT), also known as Crax, Recall # V-047-2007
CODE
23899, 23911, and 544044;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Darling International, Inc., Irving, TX, by telephone on April 20, 2007, e-mail dated April 23, 2007, and by letter dated April 24, 2007.
Manufacturer: Darling National LLC, Wichita, KS. Firm initiated recall is complete.
REASON
Product contains melamine.
VOLUME OF PRODUCT IN COMMERCE
682,600 lbs.
DISTRIBUTION
KS and NE

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

__________________________________
PRODUCT
Dry rendered tankage (DRT), also known as Crax, Recall # V-048-2007
CODE
23897, 23953, 23973, and 23937
RECALLING FIRM/MANUFACTURER
Recalling Firm: Darling International, Inc., Irving, TX, by telephone on April 20, 2007, e-mail dated April 23, 2007, and by letter dated April 24, 2007.
Manufacturer: Darling National LLC, Wichita, KS. Firm initiated recall is complete.
REASON
Product contains melamine.
VOLUME OF PRODUCT IN COMMERCE
682,600 lbs.
DISTRIBUTION
KS and NE

END OF ENFORCEMENT REPORT FOR JULY 25, 2007

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