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U.S. Department of Health and Human Services

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Enforcement Report for April 15, 2009

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.

 

April 15, 2009

09-15
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I 
___________________________________ 
PRODUCT 
Dried Yellow Potato (Papa Seca Amarilla), 12 oz. plastic bag; Net wt. 12 oz. (340 g); UPC 4133105056; Product of Peru; Recall # F-175-9
CODE 
All codes
RECALLING FIRM/MANUFACTURER 
Goya Foods Inc., Secaucus ,  NJ , by letters and press release on February 27, 2009. Firm initiated recall is ongoing.
REASON 
Product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE 
1,166 cases/24 units per case
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Guangdayuan brand Dried Sweet Potato, Net Wt. 200g --- Product of China --- UPC 6 933996 061080 --- Nutrition Facts: Serving Size 200g --- The product is packed in a sealed, flexible plastic bag, Recall # F-176-9
CODE 
Code 2008/06/01
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Domega International Co., LTD., Brooklyn ,  NY , by press release on December 31, 2008 followed up with letters.
Manufacturer: Kuizhou Foreign Trade Co. LTD., Xinhui City , Guangdong Province, China . Firm initiated recall is complete.
REASON 
The product contained undeclared sulfites (222 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE 
57 cases/50 - 200 g packages per case
DISTRIBUTION 
NY, NJ, PA, MA, OH
___________________________________ 
PRODUCT 
a) Haas Peanut Rolls, Net. Wt. 16 oz, UPC 77248 00153, and Bake Shoppe Peanut Rolls, 16 oz, UPC 77248 01298, Recall # F-177-9;
 
b) Haas Caramel Nut Coffee Cake, 4 oz, UPC 77248 00518, Recall # F-178-9;
 
c) Haas Caramel Nut Rolls, net wt. 16 oz, UPC 77248 00154, and Bake Shoppe Nut Rolls, 16 oz, UPC 77248 01299, Recall # F-179-9
CODE 
a) and c) Sell by date prior to 1/1/09
b) Five digit code ending in 08 or 07
RECALLING FIRM/MANUFACTURER 
Haas Baking Co., Affton ,   MO , by letter dated February 2, 2009 and letter and press release on February 4, 2009. Firm initiated recall is ongoing.
REASON 
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
Approximately 223,200 units
DISTRIBUTION 
MO, IL, OH, NE, KS, IA, WI, NJ, AR
___________________________________ 
PRODUCT 
McCormick brand Enchilada Sauce Mix, 1.5 oz retail pouches, packed as 12 pouchs/case, labeled in part, Item # 909160, pouch UPC 52100091600, Recall # F-180-9
CODE 
Date Codes: BEST BY AUG2910CH
RECALLING FIRM/MANUFACTURER 
McCormick & Company, Inc., Hunt Valley , MD , by press release and letter on September 30, 2008. Firm initiated recall is complete.
REASON 
The product contains milk which is undeclared on the label.
VOLUME OF PRODUCT IN COMMERCE 
1,128 cases
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II 
___________________________________ 
PRODUCT 
Crown Farms brand Bangladeshi Freshwater Fish – Gulsha CLN –Mystus cavasius – Net Wt 500 g –UPC code 5 060065 430704 – Product of Bangladesh – Keep Frozen. The packaging does not have cooking instructions and does not state that the fish is fresh frozen, Recall # F-187-9
CODE 
Date of Production AUG 2008, Best Before July 2010
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Asia Cash & Carry, Inc., Maspeth , NY , by press release on March 13, 2009.
Manufacturer: Saidowla Enterprise (BC-24), Sylhet , Bangladesh . Firm initiated recall is complete.
REASON 
The imported fish was found to be contaminated with Salmonella (spp. Poly A) based on FDA's sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE 
17 cases/16 – 500 g packages per case
DISTRIBUTION 
NY, NJ, IL, MI, VA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III 
___________________________________ 
PRODUCT 
Safeway Instant Non Fat Dry Milk, 25.6 oz box, UPC 21130 38511, Recall # F-181-9
CODE 
BEST BEFORE FEB-12, 10 55-343 and BEST BEFORE FEB-13, 10 55-343-044
RECALLING FIRM/MANUFACTURER 
The MBP Company LLC dba Marron Foods, Durand , WI , by press release on February 27, 2009 and by telephone. Firm initiated recall is ongoing.
REASON 
Product may contain aluminum fragments that came off the packaging equipment.
VOLUME OF PRODUCT IN COMMERCE 
2,688 lbs or 140 cases
DISTRIBUTION 
CO, SD, NE, TX, IL, MD, Washington DC
___________________________________ 
PRODUCT 
a) Nestum Flocos de Cereais Geracoes Saudaveis, Mel Classico. 300 g., Product is labeled entirely in Portugese. Prior to distribution, Triunfo place a label on the product - Nestle Nestum Honey Cereal, Net. Wt. 10.58 oz., Nutrition Facts and ingredients are listed in English. Product of Portugal , Recall # F-182-9;
 
b) Nestles Nestum Flocos de Cereais, Chocolate, 300 g. Product is labeled entirely in Portugese. Prior to distribution, Triunfo place a label on the product - Nestle Nestum Chocolate Cereal, Net. Wt. 10.58 oz., Nutrition Facts and ingredients are listed in English. Product of Portugal . Recall # F-183-9;
 
c) Nestle Cerelac Farinha Lactea, 500 g. Product is labeled entirely in Portugese. Prior to distribution, Triunfo place a label on the product - Nestle Cerelac Wheat Flour Cereal, Net. Wt. 17.64oz., Nutrition Facts and ingredients are listed in English. Product of Portugal . Recall # F-184-9;
 
d) Nestle Cerelac 5 Frutos, Leite de Transiaco, 500 g. Product is labeled entirely in Portugese. Prior to distribution, Triunfo place a label on the product - Nestle Cerelac 5 Fruit Cereal, Net. Wt. 17.64 oz., Nutrition Facts and ingredients are listed in English. Product of Portugal ,
Recall # F-185-9
CODE 
a) Lot # 81550301 and 81560301, Exp 9/2009;
b) Lot L82330301, Exp 11/2009 and L73550301, Exp 3/2009;
c) Lot number L73370301, Exp 6/2009;
d) Lot L81290301, Exp. 11/2009
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Triunfo Import & Export Corp., Newark , NJ , by letters dated January 14, 2009.
Manufacturer: Nestle Portugal Sa, Avanca , Portugal . Firm initiated recall is ongoing.
REASON 
Cereals contain an unapproved pesticide residue, pirimiphos methyl.
VOLUME OF PRODUCT IN COMMERCE 
4,553 cases
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Original Gourmet Original Double Chocolate Chip Cookies 0.9 oz in a metal tin containing 26 cookies. UPC 654954190029, Recall # F-186-9
CODE 
Code date C0521809B
RECALLING FIRM/MANUFACTURER 
D. F. Stauffers Biscuit Co., Inc., York , PA , by letter dated December 16, 2008. Firm initiated recall is complete.
REASON 
Product contains insect larva.
VOLUME OF PRODUCT IN COMMERCE 
698 cases
DISTRIBUTION 
Nationwide
  
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0625-09
CODE 
Units: 2906571, 2906572
RECALLING FIRM/MANUFACTURER 
Medic, Inc., Knoxville , TN , by letter on May 27, 2008. Firm initiated recall is complete.
REASON 
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0626-09
CODE 
Unit: 72J377564
RECALLING FIRM/MANUFACTURER 
Recalling Firm:  LifeSouth Community Blood Centers, Inc., Huntsville , AL , by fax on December 29, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Gainesville , FL. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0635-09
CODE 
Unit: 72J224640
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers, Inc., Huntsville , AL , by fax on October 29, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Gainesville , FL. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0641-09
CODE 
Unit: 72J093635
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers – Montgomery Region, Montgomery , AL , by fax on October 25, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets, Recall # B-0697-09
CODE 
Units: 1770438, 1770439, 1770441
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Fl, Inc., Lauderhill , FL , by facsimile on June 9, 2005. Firm initiated recall is complete.
REASON 
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
MI, FL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0700-09
CODE 
Unit: N57704
RECALLING FIRM/MANUFACTURER 
Virginia Blood Service, Inc., Richmond , VA , by letter dated April 28, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0708-09
CODE 
Unit: 72H115775
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham , AL , by facsimile on August 6, 2008. Firm initiated recall is complete.
REASON 
Blood product, with insufficient plasma volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0711-09
CODE 
Units: 53FF86034, 53FM83971
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on January 15, 2008 and follow-up letter dated January 22, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MD, CA
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0714-09;
b) Platelets, Recall # B-0715-09
CODE 
a) and b) Unit: LM08423
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter dated June 10, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
TN, MS
___________________________________ 
PRODUCT 
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0716-09;
b) Red Blood Cells, Recall # B-0717-09;
c) Platelets, Recall # B-0718-09
CODE 
a) Unit: LL95569 ( Split unit);
b) and c) Unit: LL94302
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter beginning on May 29, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
4 units
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0719-09;
b) Platelets, Recall # B-0720-09
CODE 
a) Units: LW84695; LW83167; LW82609; LW85348; LW82055; LW83941;
b) Units: LW84695; LW83941
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter dated June 17, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported travel to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
8 units
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0730-09;
b) Plasma Frozen, Recall # B-0731-09;
c) Red Blood Cells Leukocytes Reduced Irradiated, B-0732-09;
d) Fresh Frozen Plasma, Recall # B-0733-09
CODE 
a) Units 38FH54391, 38FH54393, 38KW45201, 38E29645, 38E29646, 38E29648, 38E29650, 38E29653, 38E29662, 38C57471, 38C57477, 38GZ19831, 38GZ19832, 38GZ19833, 38GZ19847, 38GZ19854, 38GZ19856, 38GZ19862, 38KF16662, 38KF16666, 38KF16673, 38KF16674, 38KF16679, 38KF16774, 38KF16779, 38KF16782, 38KF16785, 38FH54377, 38FV71311, 38KF16827, 38KF16828, 38KF16830, 38FV71683, 38FV71684, 38FV71689, 38FV71690, 38FV71692, 38FV71698, 38FV71704, 38FH54570, 38FH54571, 38FH54577, 38FH54585, 38FH54587, 38FH54589, 38FH54590, 38KT71938, 38KT71944, 38KF167913, 38C57223, 38E28939, 38E28980, 38W52778, 38W52782, 38FV69921, 38E28990, 38E29040, 38KT69830, 38KT69851, 38GE16744, 38GE16747, 38KW42545, 38KW42714, 38KW42543, 38KW42548, 38KW41523, 38KW41531, 38E28830, 38E28838, 38KT69834, 38KF15486, 38E29031, 38GE16788, 38FV71298, 38KW45146, 38FH54378, 38FH54389, 38GE16740, 38GE16741, 38FV69888, 38KF15983, 38KW41491, 38KW41521, 38E28693, 38KF15497, 38KF14667, 38KW41514, 38KF15001, 38KF15021, 38KW42550, 38KW42572, 38W53454, 38W53455, 38FV71296, 38FK53981, 38FK53996, 38GE16749, 39GE16784, 38FH53085, 38KT69469, 38KF15047, 38FV69900, 38FK16001, 38FK53472, 38FK53478, 38Y51825, 38Y51834, 38FK53593, 38FK53595, 38FK53600, 38FK53601, 38FV71279, 38FV71292, 38FH54712, 38E28681, 38E28690, 38KW42995, 38KT71952, 38KT71953, 38E28540, 38E28541, 38FH53012, 38FH53015, 38W52771, 38W52774, 38KW42652, 38KW42662, 38E28537, 38E28538, 38GZ20112, 38GZ20113, 38FV70531, 38FK53608, 38KF15953, 38KF16910, 38KF16911, 38KF15521, 38KF15524, 38FK53579, 38KT70538, 38KT69685, 38KT69688, 38FV70534, 38FV70551, 38FV71154, 38FV71161, 38KT69477, 38KT69642, 38KW42339, 38E28651, 38KW43004, 38KW43024, 38KW42716, 38KW42763, 38KF15984, 38KF15989, 38FH53006, 38FH53019, 38FK53412, 38FK53431, 38E28542, 38E28548, 38E28529, 38E28532, 38KT69652, 38KT69676, 38FV69916, 38FV69901, 38FV69913, 38FK53434, 38FK53437, 38KF14697, 38KF14699, 38W52777, 38KF14996, 38KF15516, 38KF15552, 38KT70544, 38KT70560, 38FV71274, 38FV71277, 38E28953, 38E28961, 38E28546, 38KT70531, 38KF15494, 38KF15514, 38KF15041, 38KF15042, 38KW42708, 38KW42721, 38KT70562, 38KT70568, 38KW43467, 38KW43469, 38FV71273, 38FV71162, 38FV71165, 38FV71167, 38FV71168, 38E28654, 38E28656, 38KT70552, 38E28680, 38W53451, 38FV70505, 38FV70507, 38KT69675, 38KT69819, 38E28669, 38E28687, 38KT71979, 38KT71993, 38GZ20098, 38GZ20102, 38E28894, 38E28896, 38FK53603, 38KF15846, 38KF15865, 38KF15553, 38KW42542, 38KW43511, 38KW43514, 38E28535, 38KW42338, 38KW42356, 38E28664, 38E28666, 38FH50379, 38KT69468, 38KT72000, 38KT72001, 38KW41537, 38KW41546, 38FH53023, 38FH53075, 38KF15956, 38KF15980, 38KF15048, 38E28550, 38KF14673, 38KF14674, 38GZ20074, 38GZ20086, 38KW42729, 38KW42751, 38FH53317, 38FH53320, 38KF15907, 38KF15914, 38E28908 and 38E28946;
 
b) Units: 38FH54393, 38KT72549, 38E29645, 38E29662, 38C57471, 38C57475, 38C57478, 38C57481, 38GZ19831, 38GZ19832, 38GZ19833, 38GZ19854, 38GZ19856, 38KF16673, 38KF16674, 38KF16679, 38KF16816, 38FH54377, 38FV71311, 38FV71692, 38FV71698, 38FH54575, 38FH54590, 38KT71938, 38W52778, 38GE16744, 38KW41531, 38FV71298, 38FH54378, 38GE16740, 38GE16741, 38FV69888, 38KF15983, 38E28693, 38KF15021, 38GE16749, 38FH53085, 38KF15047, 38FV69900, 38FK53600, 38E28681, 38E28690, 38KW42995, 38KT71952, 38W52771, 38W52774, 38KW42662, 38E28537, 38GZ20113, 38KF16910, 38FK53479, 38KT70538, 38KT69688, 38FV71161, 38E28651, 38KW43004, 38KW43024, 38KW42716, 38KF15984, 38KF15989, 38FK53412, 38E28532, 38FV69916, 38FV69901, 38FV69913, 38FK53434, 38FK53437, 38KT70544, 38KT70560, 38KF15041, 38KW42721, 38KT70562, 38KW43469, 38FV71272, 38FV71167, 38KT70552, 38E28680, 38W53451, 38FV70507, 38KT69819, 38E28669, 38KT71979, 38KT71993, 38E28894, 38KW43511, 38KW43514, 38KT72000, 38KW41537, 38FH53023, 38KF15048, 38FK53467, 38KF14673, 38KF14674 and 38GZ20086;
  
c) Units: 38KF16786, 38FH54575;
  
d) Unit 38E28548
RECALLING FIRM/MANUFACTURER 
American National Red Cross Indiana – Ohio Region, For Wayne, IN, by fax starting January 15, 2008. Firm initiated recall is complete.
REASON 
Blood products, possibly contaminated with air during collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
350 units
DISTRIBUTION 
AZ, CA, IN, KY, NC, OH and TN
___________________________________ 
PRODUCT 
a) Platelets Leukocytes Reduced Irradiated, Recall # B-0735-09;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0736-09;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0737-09
CODE 
a) Units: 19GY66946, 19GY66945, 19GY66926, 19GY66928, 19GY66930, 19GY66934, 19GM29689, 19LM30239, 19LM30238, 19LM30241, 19GM29691, 19GM29694, 19GH74908, 19LM30253, 19LM30261, 19LM30236, 19GY46350, 19GY46349;
 
b) Units: 19GQ16462, 19GQ16312 Part A, 19GQ16312 Part B, 19GQ15896, 19GQ15890 Part A, 19GQ15890 Part B, 19GQ15725, 19GQ15735, 19GQ15294, 19GQ12661, 19GQ13982, 19LP12966, 19GQ14861, 19GQ12097, 19GQ12090;
 
c) Units: 19LJ27519, 19LE60887, 19LM30403, 19GP26026, 19LM32095, 19GY54901, 19GV19353, 19GY59563, 19GE22388
RECALLING FIRM/MANUFACTURER 
American Red Cross Blood Services – Tennessee Valley Region, Nashville, TN, by facsimile on January 9, 2007. Firm initiated recall is complete.
REASON 
Blood products, with incomplete documentation of the irradiation process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
42 units
DISTRIBUTION 
TN, KY
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________ 
PRODUCT 
Fresh Frozen Plasma, Recall # B-0696-09
CODE 
Unit: 1506379
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S FL, Inc., Lauderhill , FL , by facsimile on March 7, 2005. Firm initiated recall is complete.
REASON 
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Red Blood Cells Frozen Rejuvenated, Recall # B-0698-09
CODE 
Unit: 1770439
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Fl, Inc., Lauderhill , FL , by facsimile on June 9, 2005. Firm initiated recall is complete.
REASON 
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MI, FL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0739-09
CODE 
Units: 0409454, 0349141, 0404027
RECALLING FIRM/MANUFACTURER 
The Blood Center , New Orleans , LA , by telephone on November 12, 2007 and by letter on November 19, 2007. Firm initiated recall is complete.
REASON 
Blood products, possibly out of controlled storage for more than 30 minutes during leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
LA, AL
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I 
___________________________________ 
PRODUCT 
Zoll AED Plus Defibrillator, Recall # Z-1206-2009
CODE 
Serial numbers below X_ _ _200000
RECALLING FIRM/MANUFACTURER 
ZOLL Medical Corp., World Wide Headquarters, Chelmsford , MA , by letter on February 12, 2009. Firm initiated recall is ongoing.
REASON 
Device fails to discharge the defibrillation energy.
VOLUME OF PRODUCT IN COMMERCE 
183,535 units
DISTRIBUTION 
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0998-2009;
 
b) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0999-2009
CODE 
a) Serial Numbers: PWH0297 PWH0212 PWH0221 PWH0309 PWH0246 PWH0250 PWH0223 PWH0429 PWH0245 PWH0292 PWH0298 PWH0214 PWH0211 PWH0210 PWH0219 PWH0216 PWH0224 PWH0215 PWH0213 PWH0220 PWH0253 PWH0252 PWH0254 PWH0221 PWH0218 PWH0217 06-2506 06-2504 05-2506 PWH0251 06-2501 06-2500 06-2503 06-2502 05-2502 and 05-2500;
 
b) Serial Numbers: PWH0267 PWH0316 PWH0269 PWH0284 PWH0201 PWH0269 PWH0264 PWH0259 PWH0226 PWH0280 PWH0278 PWH0277 05-2507 05-2505 05-2504 06-2512 PWH0262 PWH0209 PWH0274 PWH0263 PWH0239 PWH0203 PWH0244 PWH0341 PWH0257 PWH0240 PWH0315 PWH0225 PWH0234 PWH0340 PWH0232 PWH0205 PWH0204 PWH0282 PWH0230 PWH0208 PWH0265 PWH0207 PWH0200 PWH0270 PWH0202 PWH0281 PWH0279 PWH0227 PWH0255 PWH0273 PWH0206 06-2505 06-2509 05-2508 06-2508 PWH0238 PWH0237 PWH0276 PWH0229 PWH0236 PWH0228 PWH0241 06-2507 PWH0258 PWH0242 PWH0271 and PWH0233
RECALLING FIRM/MANUFACTURER 
Cardinal Health, Inc., Madison , WI , by letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. Firm initiated recall is ongoing.
REASON 
Internal testing has identified several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not operate properly. This could present itself as a lockup within approximately 20 minute of initial operation. Installation of the items will help prevent the occurrence of unexpected lockups which could result in the loss of the display information during monitoring and could lead to serious consequences during surgical monitoring.
VOLUME OF PRODUCT IN COMMERCE 
100 systems
DISTRIBUTION 
FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including Thailand, Singapore, Serbia-Montenegro, Portugal, Philippines, Poland, Norway, Netherlands, Korea, Italy, Israel, Hungary, Hong Kong, Great Britain, Spain, Germany, Czech Republic, Switzerland, Canada, Bulgaria, and Bosnia-Herzegovina
___________________________________ 
PRODUCT 
Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure, Recall # Z-1061-2009
CODE 
Lot number: 644290
RECALLING FIRM/MANUFACTURER 
Biomet, Inc., Warsaw , IN , by letter dated February 13, 2009. Firm initiated recall is ongoing.
REASON 
A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.
VOLUME OF PRODUCT IN COMMERCE 
17 units
DISTRIBUTION 
Nationwide, countries of Germany , Italy , Netherlands , Spain and the United Kingdom
___________________________________ 
PRODUCT 
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes, Recall # Z-1064-2009
CODE 
Serial No. 34001BG - 34965BG
RECALLING FIRM/MANUFACTURER 
Abbott Laboratories, Santa Clara , CA , by letter on November 17, 2008. Firm initiated recall is ongoing.
REASON 
Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
VOLUME OF PRODUCT IN COMMERCE 
604 units
DISTRIBUTION 
Nationwide, and countries of Argentina, Australia, Bermuda, Brazil, Canada, China, Chile, Columbia, Costa Rica, Ecuador, Dominican Republic, El Salvador, Guatemala, Germany, Guyana, Hong Kong, Jamaica, Japan, Mexico, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Venezuela and the Virgin Islands
___________________________________ 
PRODUCT 
a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1065-2009;
 
b) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1066-2009;
 
c) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module; GMMI No. 03284522001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1067-2009;
 
d) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1068-2009
CODE 
All units with software version 08-03
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Roche Diagnostics Corp., Indianapolis ,  IN , by letter dated November 12, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki , Japan . Firm initiated recall is ongoing.
REASON 
If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.
VOLUME OF PRODUCT IN COMMERCE 
22 modules
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Product is intended for use to facilitate the intracardiac placement of interventional devices, Recall # Z-1071-2009;
 
b) Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath, Recall # Z-1072-2009
CODE 
a) Batch Numbers: S1721 4 S1899 6 S2103 9 S2287 6 S2497 2 S1724 9 S1903 2 S2105 6 S2287 7 S2513 9 S1732 2 S1913 1 S2109 5 S2295 6 S2522 7 S1733 8 S1913 2 S2115 2 S2295 9 S2524 0 S1735 6 S1913 3 S2118 9 S2296 4 S2536 0 S1737 1 S1926 5 S2123 4 S2297 1 S2553 7 S1737 2 S1930 1 S2135 6 S2299 4 S2553 8 S1737 4 S1956 3 S2151 1 S2299 5 S2555 1 S1757 4 S1962 0 S2156 4 S2301 4 S2557 8 S1766 6 S1962 1 S2161 5 S2305 1 S2562 9 S1766 7 S1964 4 S2166 4 S2306 9 S2566 1 S1766 8 S1970 4 S2166 5 S2307 0 S2566 4 S1792 6 S2015 1 S2166 6 S2308 9 S2567 6 S1792 S2015 S2180 S2309 and S2579;
  
b) Batch Numbers: 5660, 5662, 5665, 5671, 5661, 5663, 5670 and 5676 and Batch Numbers: S17665, S2053, S1827, S2283,S2382,S20023, S2100, S1917, S2314,S2200, S21439, S2144, S1956, S2315, S2002, S22763, S2240, S2027, S2390, S2305, S2382, S2276,S2053, S2520,S23827, S17392, S2305, S2077, S2559, S1701, S18274, S2386, S2100, S2588, S1701, S19033, S2542, S2121,S2637, S2421, S19561, S1734, S2240, S1918, S20021, S1746, S2280, S2305, S1823 1 S2016 8 S2221 8 S2310 6 S2582 7 S1823 2 S2029 6 S2223 0 S2310 7 S2589 0 S1827 6 S2037 0 S2223 1 S2310 8 S2600 7 S1847 2 S2043 7 S2223 2 S2342 8 S2613 9 S1864 9 S2043 8 S2229 5 S2346 4 S2615 7 S1869 6 S2043 9 S2229 6 S2346 5 S2615 8 S1870 9 S2044 0 S2229 7 S2360 6 S2621 5 S1874 9 S2049 5 S2248 5 S2360 7 S2632 8 S1884 4 S2071 5 S2250 5 S2369 9 S2632 9 S1888 4 S2071 6 S2250 8 S2371 7 S2635 9 S1892 1 S2082 1 S2274 1 S2405 8 S2641 5 S1895 8 S2099 6 S2274 2 S2413 0 S2648 1 S1899 2 S2099 7 S2277 5 S2413 1 S1899 3 S2100 5 S2277 6 S2447 3 S1899 4 S2102 0 S2279 4 S2478 4 S1899 5 S2102 1 S2282 6 and S2493 3
RECALLING FIRM/MANUFACTURER 
Boston Scientific, Corp., San Jose , CA , by letters on December 24, 2008 and January 27, 2009. Firm initiated recall is ongoing.
REASON 
The marker band may detach from the sheath and a clinical failure could result in an embolism.
VOLUME OF PRODUCT IN COMMERCE 
31,340 units
DISTRIBUTION 
Nationwide and Internationally
___________________________________ 
PRODUCT 
a) Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1094-2009;
 
b) GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1095-2009
CODE 
a) H2508PY: S/N 16076 16010 16177, and 16175. H3000WN: 16433 and 16366 H3000WR: 16275, 16306, and 16379. H3000WW: 16584 16690 16146 16328 16292 16530 16574 16619 16321 16545 16586 16193 16351 16393 16435 16439 16471 16217 16274 16459 16438 17022 16347 16302 16717 16689 16989 16998 17039 16480 16584 16593 16568 16458 16951 16711 16417 16906 17038 16458 16727 16003 16247 16386 16729 16402 16398 16529 16708 16277 16754 16294 16604 16591 16642 16383 16463 16268 16554 16690 16467 16357 16316 16879 16367 16745 16535 16675 16581 16399 16501 16507 16222 16461 16602 16769 16782 16956 16836 16445 16493 16384 16486 16693 16894 16343 16452 16801 16631 16633 16931 16631 16618 16200 16702 16818 16341 16556 16299 16345 16329 16753 16348 16257 16610 16258 16707 16369 16253 16958 16284 16703 16252 16638 16254 16278 16333 16231 16368 16709 16265 16488 16884 16330 16845 16558 16630 16490 16855 16563 16599 16431 16414 16714 16327 16360 16647 16577 16883 16625 16605 16201 16892 16603 16652 16623 16339 16671 16270 16407 16476 16416 16390 16451 16424 16952 16276 16236 16496 16895 16484 16654 16620 16230 16406 16985 16359 16273 16597 16482 16429 16338 16607 16388 16847 16573 16606 16824 16472 16981 16374 16835 16562 16288 16241 16609 16203 16508 16342 16363 16444 16260 16678 16342 16202 16598 16550 16615 16440 16362 16506 16272 16389 16936 16332 16508 16521 16687 16629 16588 16700 16358 16307 16432 16595 16997 16787 16590 16653 16580 16287 16514 16515 16555 16777 16192 16555 16199 16385 16764 16544 16232 16523 16256 16954 16982 16309 16242 16257 16644 16797 16267 16283 16280 16549 16596 16637 16691 16697 16757 16980 16681 16684 16679 16730 16546 16352 H3000WY: 16616 17083 16282 16897 16532 16143 16423 16204 17085 16423, and 16289. H3000WZ: 16350 16752 16375 16582 16237 16238 16183 16176 16403 16468 17148 16239 16349 16572 16996 16086 16240 16552 16485 16815 16813 16826 17079 16601 16495 16522 16240 16264 16248 16624 16961 16780 16409 16205 16387 16487 16481 16891 16449 16361 16215 16831 16462 16261 16512 16578 16197 16205 16565 16430 16397, and 16251. H3000YM: 16146 16057 16133 16100 16157 16172 16024 16174 16147 16125 16164 16120 16131 16127 16132 16040 16024 16128 16052 16055 16070 16013 16011 16029 16110 16028 16009 16060 16173 16008 16082 16027 16151 16153 16154 16064 16163 16007 16030 16037 16124 16046 16020 16112 16121 16103 16063 16169 16035 16042 16059 16109 16021 16159 16062 16073 16148 16149 16156 16053 16038 16019 16023 16078 16150, and 16101. H3000YS: 16061 16134 16095 16085 16152 16089 16074 16168 16141 16067 16068, and 16056;
 
b) H3000WC : S/N 17032 17391 16844 17215 16974 16979 17090 16898 16967 17136 17057 17130 17121 17337 17298 17376 17208 17114 16876 17164 17247 17276 17286 17293 17317 17070 17391 17220 16905 17011 16850 16947 17347 17082 16880 16910 17288 16933 17061 17198 16994 17265 16820 17106 17058 17047 17053 17116 16852 17169 17029 17195 17169 16938 17125 16970 16774 17226 16886 17118 16945 17348 16924 16888 16811 17122 17389 17020 17135 16962 17101 16849 17233 17137 17300 17299 17268 16960 17326 17050 17269 17131 17204 17349 17034 17005 17213 17301 17019 16987 17108 17088 17166 17287 17099 17023 16927 17328 17174 17042 16821 16914 16972 17285 17323 17104 17241 17258 17249 17109 16977 16946 16975 17162 17002 16862 16869 17219 16887 16950 16949 16874 17147 16965 16889 17290 17055 17185 16966 17046 17112 17041 17289 17178 17103 17139 17260 16986 17000 17105 17390 17331 17098 17297 17052 17089 17373 17264 16871 17199 17190 17124 17382 16925 17159 17062 17372 16944 17173 17388 16885 17254 17187 17278 16934 16901 17231 17295 16932 16893 17025 17100 16878 16955 17360 16921 16922 16838 16876 16865 16926 16856 16928 16930 17333 17018 17363 17277 16968 17024 17210 17172 17251 17197 16911 16978 17049 16919 17338 17179 17259 17248 17351 17238 17165 17048 17206, and 17158. H3000WD: 17154 17310 17113 17072 17163 17236 17067 17107 17346 17252 17126, and 17379
RECALLING FIRM/MANUFACTURER 
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April, 2008.
Manufacturer: GE Medical System, Tirat Hacarmel , Israel . Firm initiated recall is ongoing.
REASON 
There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.
VOLUME OF PRODUCT IN COMMERCE 
639 units
DISTRIBUTION 
Nationwide, and countries of Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Denmark, Ecuador, Finland, France, Georgia, Germany, India, Indonesia, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom
___________________________________ 
PRODUCT 
a) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1096-2009;
 
b) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1097-2009;
 
c) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1098-2009;
 
d) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1099-2009;
 
e) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1100-2009;
 
f) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1101-2009;
 
g) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1102-2009;
 
h) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1103-2009;
i) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1104-2009;
 
j) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1105-2009;
 
k) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1106-2009;
 
l) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1107-2009;
 
m) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1108-2009;
 
n) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1109-2009;
 
o ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1110-2009;
 
p) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1111-2009;
 
q ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1112-2009;
 
r) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1113-2009;
 
s) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1114-2009;
 
t) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1115-2009;
 
u) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1116-2009;
 
v) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1117-2009
CODE 
a) Lot numbers: HUSC0041, HUSC0042, HUSD0281, HUSD0326, HUSD1983, HUSD1984, HUSE1554, HUSF1907, HUSF1908, HUSG1086, HUSG1087, HUSH1621, HUSH1651, HUSI2748 and HUSI2749;
 
b) Lot numbers: HUSA0398, HUSA1482, HUSA1483, HUSC0043, HUSC0044, HUSD0282, HUSD0327, HUSD1985, HUSD1986, HUSE1555, HUSF1909, HUSG0010, HUSG1088, HUSH1632, HUSH1652 and HUSI2750;
 
c) Lot numbers: HUSC0045, HUSC2106, HUSD0283, HUSD1987, HUSD1988, HUSE1556, HUSF1910, HUSF1911, HUSG0498, HUSG1089, HUSG1090, HUSH1622, HUSH1653, HUSI2701 and HUSI2751;
 
d) Lot numbers: HUSB0169, HUSC0046, HUSD0328, HUSD1989, HUSD1990, HUSE1557, HUSG1091, HUSG1092, HUSH1633 and HUSI2752;
 
e) Lot numbers: HUSA0401, HUSC0047, HUSC0048, HUSD0284, HUSD0329, HUSD1991, HUSD1992, HUSE0948, HUSE1558, HUSF1912, HUSG1096, HUSG1098, HUSH1634, HUSH1654, HUSI2702 and HUSI2753;
 
f) Lot numbers: HUSB1653, HUSB1654, HUSC0049, HUSD0330, HUSD0331, HUSD1614, HUSD1913, HUSD1993, HUSE1559, HUSE1560, HUSF1282, HUSF1913, HUSF1914, HUSG1099, HUSG1100, HUSG1101, HUSH1623, HUSH1624, HUSH1655, HUSI2754, HUSI2755 and HUSI2756;
 
g) Lot numbers: HUSB1655, HUSB1656, HUSC0050, HUSC0051, HUSC0052, HUSD0285, HUSD0332, HUSD0333, HUSD1191, HUSD1615, HUSD1994, HUSD1996, HUSE1561, HUSE1562, HUSF1283, HUSG1102, HUSG1103, HUSG1104, HUSH0472, HUSH1625, HUSH1626, HUSH1656, HUSI2757, HUSI2758, HUSI2759 and HUSI2760;
 
h) Lot numbers: HUSA0411, HUSA0412, HUSC0040, HUSD0334, HUSD0335, HUSD1910, HUSD1997, HUSE1563, HUSF1284, HUSF1915, HUSG1105, HUSH1604 and HUSI2761;
 
i) Lot numbers: HUSA0415 and HUSI2762;
 
j) Lot numbers: HUSA0416, HUSD0336 and HUSI2763;
 
k) Lot numbers: HUSA0421, HUSD0337, HUSD1998, HUSF1916, HUSG1107, HUSH1657 and HUSI2764;
 
l) Lot numbers: HUSA0422, HUSD0338, HUSD1999, HUSF1917, HUSG1108, HUSH1658 and HUSI2765;
 
m) Lot numbers: HUSA0435, HUSD0286, HUSD2000, HUSH1659 and HUSI2766;
 
n) Lot numbers: HUSB0170, HUSC0071, HUSC0072, HUSC2107, HUSD2001, HUSD2002, HUSE1564, HUSF1918, HUSG1109, HUSH1605, HUSH1660 and HUSI2767;
 
o) Lot numbers: HUSA0438, HUSB0171, HUSC0073, HUSD0339, HUSD0340, HUSD1911, HUSD2003, HUSE1565, HUSE1566, HUSF1285, HUSF1919, HUSG1110, HUSG1111, HUSH1635, HUSH1661, HUSI2703, and HUSI 2707;
 
p) Lot numbers: HUSB1657, HUSB1658, HUSC0106, HUSC0107, HUSD0341, HUSD1912, HUSD2004, HUSD2183, HUSE1567, HUSF1286, HUSG1112, HUSH1636, HUSH1662 and HUSI2708;
 
q) Lot numbers: HUSB0172, HUSC0114, HUSD0342, HUSD0343, HUSD2005, HUSE1568, HUSF1921, HUSG1113, HUSH1606, HUSH1665, and HUSI2710;
 
r) Lot numbers: HUSA0453, HUSD2008, HUSF1922, HUSG0671 and HUSI2768;
 
s) Lot numbers: HUSA0454, HUSA0455, HUSA1490, HUSC0128, HUSD0345, HUSD0346, HUSD2009, HUSD2010, HUSE1570, HUSE1571, HUSF1923, HUSF1924, HUSG1116, HUSG1117, HUSH1297, HUSH1627, HUSH1666, HUSI2769 and HUSI2770;
  
t) Lot numbers: HUSB0174, HUSC0130, HUSC2109, HUSD0347, HUSD0569, HUSD2011, HUSD2012, HUSE0954, HUSE1572, HUSE1573, HUSF1927, HUSF1928, HUSG1118, HUSG1119, HUSH1628, HUSH1667, HUSI2771 and HUSI2772;
 
u) Lot numbers: HUSA0458, HUSA0459, HUSC0131, HUSC1295, HUSD0348, HUSD0349, HUSD2013, HUSD2014, HUSE0894, HUSE1574, HUSF1925, HUSF1926, HUSG1120, HUSH1629, HUSH1668, HUSI2711 and HUSI2773;
 
v) Lot numbers: HUSA0460, HUSB0188, HUSC0132, HUSD0350, HUSD2015, HUSD2016, HUSE1575, HUSF1929, HUSG1121, HUSH1637, HUSH1669 and HUSI2712
RECALLING FIRM/MANUFACTURER 
Recalling Firm: C R Bard, Inc., Salt Lake City , UT , by letter on January 7, 2009.
Manufacturer: Bard Puerto Rico , Las Piedras, PR. Firm initiated recall is ongoing.
REASON 
Out of specification replacement gastrostomy device was distributed.
VOLUME OF PRODUCT IN COMMERCE 
29,939 units
DISTRIBUTION 
NV, PA, WV, CA and NC, and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America
___________________________________ 
PRODUCT 
a) GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ASM001620 ASM500016 H3000WM H3000WT H3000WY and SYS000041. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1119-2009;
 
b) GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1120-2009;
 
c) GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1121-2009
CODE 
a) Model Number ASM000886: 16017 16004 16007 16012 16006 16008 16010 16023 16039 16026 16025 16015 16052 16022 16055 16065 16027 16142 16084 16101 16030 16054 16079 16042 16064 16062 16109 16060 16100 16097 16129 16125 16130 16160 16110 16136 16151 16161 16145 16184 16173 16156 16080 16178 16126 16113 16096 16107 16170 16003 16059 17049 17029 17061 17050 17052 17046 17029 17068 and 17154; Model Number ASM001333: 16001 16049 16043 16040 16028 16009 16051 16053 16044 16037 16015 16099 16035 16048 16020 16053 16013 16026 16036 and 16014; Model Number ASM001391: 16063 16076 16073 16102 16106 16088 16075 16122 16124 16074 16120 16083 16149 16152 16056 16150 16153 16105 16162 16182 16163 16166 16188 16132 16058 16167 16131 16216 16168 16217 16221 16179 16164 16094 16169 16187 16090 16172 16177 16175 16093 16183 16186 16091 16246 16238 16041 16174 16104 16050 16073 16140 16078 16139 16158 and 16067; Model Number ASM001465: 16195 16192 16205 16198 16212 16219 16210 16206 16193 16227 16270 16273 16203 16267 16281 16288 16200 16313 16342 16294 16330 16286 16303 16327 16299 16332 16243 16252 16333 16290 16364 16360 16339 16335 16344 16245 16381 16385 16176 16377 16362 16366 16388 16320 16334 16399 16384 16380 16412 16413 16411 16236 16369 16432 16428 16289 16404 16405 16408 16256 16414 16429 16365 16427 16433 16394 16343 16230 16441 16426 16443 16435 16439 16470 16471 16391 16223 16466 16475 16376 16464 16455 16511 16349 16510 16514 16515 16500 16532 16451 16538 16493 16533 16537 16547 16487 16395 16482 16505 16528 16517 16549 16560 16529 16508 16520 16564 16445 16438 16476 16278 16378 16347 16211 16415 and 16421; Model Number ASM001473: 16254 16276 16316 16314 16308 16283 16323 16298 16326 16284 16280 16262 16345 16331 16291 16337 16312 16352 16371 16346 16355 16368 16315 16356 16266 16379 16410 16398 16321 16416 16293 16340 16374 16429 16318 16406 16420 16319 16456 16440 16450 16449 16477 16460 16329 16302 16492 16474 16448 16499 16498 16490 16478 16430 16494 16496 16309 16400 16491 16452 16419 16328 16397 16462 16191 16418 and 16495; Model Number ASM001620: 16581 16574 16592 16645 16632 16622 16611 16661 16668 16595 16625 16587 16656 16708 16629 16638 16566 16663 16617 16694 16721 16692 16673 16742 16702 16738 16675 16745 16725 16715 16719 16688 16613 16726 16704 16714 16777 16674 16776 16805 16645 16770 16782 16759 16791 16837 16798 16836 16830 16842 16766 16853 16616 16577 16847 16835 16857 16851 16860 16824 16858 16834 16653 16818 16894 16752 16736 16883 16655 16870 16875 16896 16594 16902 16801 16868 16881 16909 16943 16897 16941 16939 16942 16819 16867 16810 16877 16940 16890 16839 16980 16668 16989 16740 16717 16956 16997 17083 16923 17022 16996 16705 17039 and 16695; Model Number ASM500016: 16501 16522 16534 16535 16576 16575 16553 16516 16506 16562 16557 16542 16541 16551 16602 16573 16614 16583 16586 16571 16607 16569 16578 16621 16649 16635 16669 16593 16639 16647 16681 16660 16580 16684 16679 16677 16686 16646 16657 16667 16637 16693 16699 16689 16665 16654 16676 16666 16697 16718 16610 16701 16563 16716 16579 16424 16710 16698 16707 16733 16747 16584 16706 16709 16765 16239 16605 16725 16741 16768 16749 16751 16779 16746 16750 16792 16773 16536 16780 16790 16769 16600 16797 16814 16817 16807 16802 16601 16690 17030 and 16815; Model Number H3000WM: 16353; Model Number H3000WT: 16115 16207 16224 16229 16220 16208 16235 16244 16234 16250 16279 16295 16269 16301 16285 16293 16324 16255 16271 16370 16233 16372 16422 16442 16382 16437 16453 16425 16457 16454 16465 16259 16469 16509 16519 16497 16527 16479 16531 16524 16434 16489 16567 16539 16502 16446 16311 16627 16640 16608 16636 16641 16634 16540 16659 16628 16643 16658 16209 16228 16685 16626 16513 16548 16664 16672 16559 16670 16662 16720 16696 16734 16713 16763 16735 16748 16761 16767 16775 16803 16762 16536 16783 16812 16310 16392 16731 16788 16728 16723 16214 16504 16799 16502 16249 16503 16756 16760 16680 16376 16518 16612 16525 16300 16297 16447 16732 16786 16710 16758 16786 16731 16213 16808 16804 16135 16848 16800 16833 16816 16806 16789 16822 16841 16840 16839 16829 16832 16437 16587 16866 16861 16863 16825 16900 16916 16872 16882 16908 16917 16772 16929 16935 16920 16778 16959 16964 16196 16263 16305 16913 16526 16648 16796 16991 16912 17003 17031 17006 17056 17012 16971 16983 16851 17009 17027 17073 17014 17074 17064 17043 17117 17080 17155 17059 17142 17160 17152 17123 16296 16904 17146 17212 17177 17216 17218 17015 17223 16993 16218 17184 17234 17246 17275 17282 17274 17257 17279 17291 17134 17270 17196 17308 17302 17230 16984 17261 17334 17355 17315 17242 17168 17283 16973 17378 17371 17380 17393 17409 17396 17292 17221 17186 and 16483; Model Number H3000WY: 16282 16204 16423 16143 16423 and 17085; and Model Number SYS000041: 16005 16034 16018 16045 16092 16016 16123 16098 16072 16084 16111 16136 16108 16155 16116 16180 16189 16185 and 16137;
 
b) Model Number H3000WR: 16306 and 16275; Model Number H3000WW: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544; Model Number H3000WZ: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148; Model Number H3000YM: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133; and Model Number H3000YS: 16068 16089 16141 16085 and 16061;
 
c) Model Number 5178728: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241; Model Number ASM500060: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070; Model Number H3000WC: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and Model Number HH3000WD: 17072 17126 17067 17107 17163 17236 17346 and 17379
RECALLING FIRM/MANUFACTURER 
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April 2008.
Manufacturer: GE Medical System, Tirat Hacarmel , Israel . Firm initiated recall is ongoing.
REASON 
The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 
1,256 devices
DISTRIBUTION 
Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, Finland, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom
___________________________________ 
PRODUCT 
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents, Recall # Z-1170-2009
CODE 
Lot Numbers: 8105650 8105554 8105467 8105466 8105421 8105176 8105424 8105322 8105092 8105175 8105094 8105174 8105002 8105084 8105001 8105003 8096111 8096036 8095983 8095872 8095373 8095854 8095733 8095748 8095683 8095512 8095424 8095372 8095295 8095299 8095217 8095116 8095114 8095003 8095002 8095001 8095006 8085820 8085729 8085623 8085566 8085567 8085520 8085454 8085394 8085314 8085279 8085199 8085184 8085003 8085006 8085005 8085004 8085002 8085001 8075963 8075932 8075924 8075846 8075769 8075679 8075782 8075675 8075590 8075588 8075522 8075471 8075465 8075414 8075374 8075413 8075280 8075277 8075182 8075177 8075123 8075119 8075118 8075004 8075014 8075003 8075002 8075001 8065668 8065683 8065667 8065507 8065504 8065408 8065224 8065409 8065376 8065223 8065332 8065178 8065176 8065108 8065107 8065003 8065002 8065001 8055718 8055665 8055664 8055662 8055627 8055598 8055567 8055522 8055478 8055474 8055312 8055404 8055413 8055282 8055281 8055241 8055166 8055221 8055165 8055126 8055072 8055063 8055044 8055002 8055001 8055003 8046137 8046064 8046002 8045985 8045930 8045883 8045923 8045812 8045864 8045798 8045738 8045767 8045719 8045569 8045638 8045565 8045518 8045478 8045367 8045180 8045440 8045360 8045336 8045222 8045114 8045017 8035669 8045002 8045067 8045001 8035639 8035363 8035362 8035196 8035320 8035173 8035319 8035250 8035459 8035194 8035249 8035122 8035018 8035002 8035003 8035001 8025647 8025502 8025688 8025585 8025209 8025130 8025406 8025503 8025290 8025324 8025208 8025174 8025079 8025156 8025003 8025004 8015789 8025002 8025001 8015863 8015921 8015741 8015784 8015684 8015685 8015637 8015638 8015564 8015547 8015548 8015498 8015326 8015227 8015478 8015281 8015226 8015108 8015003 8015058 8015002 8015057 8015001 7125677 7125744 7125732 7125652 7125602 7125563 7125527 7125516 7125437 7125439 7125284 7125355 7125304 7125205 7125165 7125158 7125126 7125108 7115565 7125003 7125002 7115858 7125001 7115796 7115767 7115634 7115631 7115683 7115476 7115583 7115369 7115439 7115420 7115283 7115368 7115229 7115134 7115225 7115078 7115074 7115001 7115004 7115003 7105847 7105743 7105839 7105789 7105778 7105741 7105742 7105634 7105600 7105211 7105456 7105448 7105447 7105248 7105312 7105157 7105004 7105078 7105003 7105001 7105002 7095846 7095355 7095844 7095736 7095737 7095559 7095584 7095439 7095237 7095440 7095175 7095135 7095093 7095004 7095003 7095002 7095001 7088687 7088517 7088516 7088515 7088550 7088309 7088381 7088308 7088305 7088199 7088198 7088184 7088185 7088112 7088110 7088111 7085260 7085259 7085166 7085222 7085051 7085003 7085167 7085123 7085002 7085145 7085005 7085001 7076045 7075841 7075709 7075792 7075708 7075580 7075678 7075476 7075352 7075448 7075447 7075159 7075405 7075068 7075160 7075066 7075005 7075002 7075001 7075004 7075003 7065851 7065897 7065850 7065763 7065762 7065647 7065736 7065544 7065601 7065602 7065510 7065418 7065179 7065366 7065004 7065309 7065127 7065231 7065036 7065003 7065002 7065001 7055764 7055654 7055714 7055653 7055631 7055548 7055537 7055536 7055521 7055296 7055378 7055224 7055222 7055175 7055001 7055174 7055078 7055061 7055003 7055002 7045756 7045755 7045681 7045577 7045682 7045515 7045512 7045466 7045269 7045467 7045397 7045347 7045313 7045060 7045224 7045177 7045172 7045119 7045118 7045061 7045055 7045002 7045001 7045003 7035919 7035815 7035799 7035818 7035798 7035656 7035769 7035490 7035489 7035600 7035451 7035448 7035243 7035297 7035181 7035125 7035124 7035003 7035002 7035001 7025703 7025604 7025614 7025604 7025528 7025459 7025423 7025370 7025315 7025284 7025188 7025091 7025069 7025054 7025038 7025037 7015881 7015841 7015737 7015736 7015626 7015619 7015475 7015091 7015406 7015474 7015409 7015408 7015330 7015407 7015329 7015279 7015280 7015236 7015235 7015194 7015193 7015090 7015045 7015041 7015040 7015001 6125411 6125326 6125553 6125552 6125124 6125119 6125118 6125433 6125410 6125123 6125262 6125261 6125325 6125001 6125122 6125002 6125117 6125050 6125003 6115978 6115829 6115769 6115768 6115540 6115539 6115394 6115521 6115392 6115393 6115325 6115364 6115324 6115180 6115071 6115178 6115069 6115010 6115066 6115008 6115007 6115009 6105796 6105732 6105795 6105794 6105689 6105731 6105688 6105661 6105660 6105594 6105593 6105554 6105553 6105173 6105474 6105465 6105464 6105304 6105305 6105172 6105303 6105117 6105108 6105040 6105039 6095621
RECALLING FIRM/MANUFACTURER 
Cardinal Health 303 dba Cardinal Health, San Diego , CA , by letter, dated December 19, 2008. Firm initiated recall is ongoing.
REASON 
The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.
VOLUME OF PRODUCT IN COMMERCE 
Approximately 2.6 million units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Internal Sterilizable Paddles and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. Internal Defibrillation Handles without discharge control: Part Numbers 800441-03 thru 800441-06 Internal Defibrillation Electrodes (threaded end): Part Numbers: 802154-10 thru 802154-19, Recall # Z-1171-2009
CODE 
Sterilization labeling affects ALL part numbers referenced above.
RECALLING FIRM/MANUFACTURER 
Physio Control, Inc., Redmond , WA , by letters, dated February 2, 2009. Firm initiated recall is ongoing.
REASON 
Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
VOLUME OF PRODUCT IN COMMERCE 
3,218 units
DISTRIBUTION 
Nationwide and Internationally
___________________________________ 
PRODUCT 
Integra Bilayer Matrix Wound Dressing, 8 “ x 10” (20 cm x 25 cm); Non-pyrogenic, Do not Re-sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810, Recall # Z-1174-2009
CODE 
Lot number: 105BA0105205
RECALLING FIRM/MANUFACTURER 
Integra LifeSciences, Corp., Plainsboro , NJ , by letters dated March 10, 2009. Firm initiated recall is ongoing.
REASON 
Integra became aware of the potential of open seals in the foil pouch of the wound dressings.
VOLUME OF PRODUCT IN COMMERCE 
125 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Recall # Z-1175-2009;
 
b) Pilling(R) Coronary Scissors, 45Deg 7", Catalog numbers: 352165, Recall # Z-1176-2009;
  
c) Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, Recall # Z-1177-2009;
 
d) Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167, Recall # Z-1178-2009;
 
e) Pilling(R) Coronary Scissors, 120Deg 7", Catalog numbers: 352168, Recall # Z-1179-2009;
 
f) Beall(R) Circumflex Artery Scissors, Catalog numbers: 352169, Recall # Z-1180-2009;
 
g) Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, Recall # Z-1181-2009
CODE 
a) through g) Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Teleflex Medical, Durham , NC , by letter dated March 3, 2009.
Manufacturer: Teleflex Medical, Research Triangle Park , NC . Firm initiated recall is ongoing.
REASON 
The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
VOLUME OF PRODUCT IN COMMERCE 
497 units
DISTRIBUTION 
Nationwide and countries of Australia , Canada , France , Germany , India , Japan , and Singapore
___________________________________ 
PRODUCT 
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis, Recall # Z-1204-2009
CODE 
Sublot of lot 088061, expiration date 2008-12
RECALLING FIRM/MANUFACTURER 
DiaDexus, Inc., South San Francisco , CA , by telephone and letter on November 4, 2008. Firm initiated recall is ongoing.
REASON 
Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
VOLUME OF PRODUCT IN COMMERCE 
27 kits
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III 
___________________________________ 
PRODUCT 
ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease, Recall # Z-1044-2009
CODE 
Sub Assembly Lot Numbers: 0823200, 0823201, and 0825500 and Kit Lot Numbers: 826305, 0827311, 0828107, 0828108, 0828109, 0830914, 0831607, 0831606, 0829719, 0827315, 0827301, 0829413, 0829512, 0826905, 0828114, 0828804, 0829414, 0829721, 0830300, 0828307 and 0829513
RECALLING FIRM/MANUFACTURER 
Immuno Concepts, Inc., Sacramento , CA , by letter, e-mail and telephone December 4, 2008. Firm initiated recall is ongoing.
REASON 
Samples can occasionally run out of the wells and cross contaminate adjacent wells.
VOLUME OF PRODUCT IN COMMERCE 
378 kits
DISTRIBUTION 
NC, WI, MS, MD, IL, GA, CA, MI, PR, and Sweden , Mexico , Spain , and Denmark
___________________________________ 
PRODUCT 
Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, Recall # Z-1172-2009
CODE 
v1.0 software
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN, by letters dated November 2008, and December 10, 2008.
Manufacturer: Medtronic, Inc., Minneapolis ,  MN . Firm initiated recall is ongoing.
REASON 
Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
VOLUME OF PRODUCT IN COMMERCE 
55,755 units
DISTRIBUTION 
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands
  
END OF ENFORCEMENT REPORT FOR APRIL 15, 2009

 

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