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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 01FJ07492A; 01FJ07492B;01FJ07493A; 01FJ07493B; 01FJ07494A; 01FJ07494B Class III Blood products, which may have been transported under unacceptable temperatures after collection, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced LX62656 Class II Blood product, collected from a donor who was considered at risk for human immunodeficiency virus (HIV) Group O, was distributed. LifeServe Blood Center
Biologics Platelets Leukocytes Reduced Irradiated 2411524B Class II Blood product, with an unacceptable platelet yield, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 9929659 Class III Blood product, that was irradiated twice, was distributed Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W137507102679; 7242381; 7239762. Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed Lane Memorial Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 20GH52851 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross
Biologics Source Plasma 367094508, 367093944, 367095063 Class II Blood products, which were not tested for viral markers, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 07IMOG3145;07IMOG3633;07IMOG4399;07IMOG5428; 07IMOG7544;07IMOG8065;07IMOG9727;08IMOA1536; 08IMOA2184;08IMOA3310;08IMOA3940;08IMOA5130; 08IMOA5775;08IMOA6926;08IMOA7545;08IMOA8600; 08IMOA9170;08IMOB0195;08IMOB0120;08IMOB1852; 08IMOB2406;08IMOB3476;08IMOB4110;08IMOB6915; 08IMOB7535;08IMOB8596;08IMOB9162;08IMOC0356; 08IMOC1016;08IMOC2529;08IMOC3217;08IMOC4380; 08IMOC5073;08IMOC6209;08IMOC6880;08IMOC9283; 08IMOC9918;08IMOD1004;08IMOD1628;08IMOD2715; 08IMOD3403 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. BioLife Plasma Services LP
Biologics Red Blood Cells Leukocytes Reduced 01GJ97127 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01GJ97127 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 366079288; 366079360; 366082135; 366083179; 366084190; 366084634; 366085317; 366087202; 366087644; 366088694; 366089200; 366090702; 366091164; 366092335; 366093126; 366094294; 366095581; 366096218; 366085779, 366097224, 366097722, 366099231, 366099613, 366100689, 366101179, 366105600, 366107419, 366108864, 366109940, 366110474, 366111772, 366114206, 366121907, 366122282 Class II Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3740050804; 3740051489; Class III Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 4240016562 4240016227 4240015380 4240019033 4240017662 4240017149 4240016718 4240016220 4240015901 4240030578 4240030110 4240016888 4240016386 4240015849 4240031050 4240030277 4240029767 4240029010 4240027582 4240026960 4240026400 4240025974 4240025449 4240023612 4240021904 4240020798 4240019172 4240018309 4240017985 4240031664 4240030930 4240030040 4240029138 4240028890 4240027868 4240027424 4240026619 4240025983 4240025072 4240024643 4240024006 4240023727 4240022978 4240022487 4240022051 4240021532 4240021026 4240020416 4240019859 4240018893 4240018118 4240017413 4240017098 4240031569 4240031145 4240022279 4240021514 4240020986 4240020217 4240019301 4240018474 4240024389 4240023957 4240023324 4240022314 4240021943 4240020942 4240020343 4240017705 4240017037 4240016854 4240016974 4240016003 4240031444 4240030845 4240030296 4240029609 4240029159 4240028483 4240028008 4240027314 4240026695 4240025384 4240024794 4240024300 4240023723 4240023240 4240022725 4240022260 4240021740 4240021248 4240020715 4240019773 4240019229 4240018847 4240017527 4240017196 4240015773 4240015201 4240028382 4240027207 4240026812 4240025011 4240024238 4240023782 4240023276 4240022528 4240022215 4240021646 4240019351 4240017364 4240016660 4240015994 4240018750 4240018439 4240020270 4240019348 4240018999 4240018453 4240018146 4240017498 4240017506 4240016406 4240015740 4240024979 4240024268 4240023664 4240022810 4240022245 4240021855 4240021278 4240020674 4240020299 4240015135 4240018949 4240018538 4240017921 4240017763 4240017128 4240022320 4240021553 4240020538 4240019964 4240018725 4240018177 4240017849 4240017396 4240017141 4240032046 4240031443 4240030744 4240030299 4240029608 4240029165 4240028482 4240028007 4240027315 4240026696 4240025246 4240024818 4240023728 4240023109 4240022717 4240022119 4240021732 4240021124 4240020712 4240020135 4240019780 4240019231 4240018853 4240016676 4240016320 4240015756 4240015180 4240024525 4240024131 4240015900 4240015435 4240021571 4240020876 4240018517 4240018133 4240017664 4240032147 4240031623 4240030990 4240028535 4240028036 4240027422 4240026779 4240018232 4240016692 4240016184 4240015669 4240029499 4240028885 4240027184 4240026221 4240025289 4240024617 4240023463 4240023051 4240021944 4240020989 4240019505 4240019120 4240018459 4240017894 4240017397 4240031420 4240030961 4240030412 4240029965 4240029264 4240028784 4240028126 4240027734 4240027023 4240026562 4240026001 4240025645 4240024909 4240024463 4240023827 4240023402 4240022807 4240022116 4240021726 4240021024 4240020611 4240020035 4240019628 4240019086 4240018569 4240018313 4240018751 4240018216 4240017060 4240015349 4240018564 4240018161 4240017299 4240016479 4240015601 4240018866 4240018431 4240016325 4240015925 4240017940 4240017485 4240017159 4240032144 4240031609 4240030976 4240030596 4240029886 4240029418 4240028729 4240028294 4240027597 4240027141 4240026567 4240026201 4240025327 4240024959 4240024221 4240023802 4240023004 4240022542 4240021379 4240020877 4240019328 4240017887 4240017773 4240017186 4240025047 4240017081 4240016217 4240015971 4240015322 4240015167 4240019531 4240019212 4240018583 4240018329 4240017806 4240017348 4240016952 4240016264 4240017816 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 4240013647;4240013121;4240012766;4240012300; 4240012033;4240011179;4240010766;4240010449; 4240006845;4240026822;4240018069;4240017563; 4240017259;4240016368;4240015639;4240015315; 4240014793;4240014514;4240010109 ,4240009093 , 4240008806 ,4240008423 ,4240008143 ,4240007781 , 4240007410 ,4240007180 ,4240006880 ,4240022328 , 4240021971 ,4240011906 ,4240010160 ,4240009557 , 4240008949 ,4240008764 ,4240007707 ,4240006878 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W066509675798, W066509675749, W066509675728, W066509657517, W066509657518, W066509657532, W066509675814, W066509678095, W066509677794, W066509677801, W066509658117, W066509657524, W066509657540, W066509657556, W066509675781, W066509675730, W066509675741, W066509677810, W066509677815, W066509677433, W066509657515, W066509657558, W066509675892, W066S09675808, W066509675793 , W066509675802, W066509675804, W066509657532, W066509675692, W066509658672, W066509658119. Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.. Blood Bank of Alaska, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W066509658119, W066509675793, W066509677433; W06650975802 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.. Blood Bank of Alaska, Inc.
Biologics Blood and Blood Products for Reprocessing 020LE34036, 020LE34040, 020LE34041, 020LE34043, 020LE34044, 020LE34045, 020LE34046, 020LE34048, 020LE34051, 020LE34053, 020LE34054, 020LE34055, 020LE34056, 020LE34059, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34064, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34073, 020LE34074, 020LE34075, 020LE34076, 020LE34077, 020LE34078, 020LE34079, 020LE34080, 020LE34081. Class III Blood products, possibly contaminated with air, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 020LE34037 , 020LE34039 , 020LE34041 , 020LE34042 , 020LE34046, 020LE34047, 020LE34048, 020LE34049, 020LE34050, 020LE34051, 020LE34052, 020LE34054, 020LE34056, 020LE34057, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34074, 020LE34076, 020LE34077, 020LE34078, Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross
Biologics Plasma Frozen Within 24 Hours After Phlebotomy (FP24) 020LE34038, 020LE34049, 020LE34052, 020LE34057, 020LE34058. Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross
Biologics Source Plasma 3720428066; 3720425381; 3720421643; 3720420290; 3720418232; 3720416926; 3720415044; 3720413553; 3720411637; 3720410338; 3720407547; 3720405571; 3720404375; 3720402283; 3720400924; 3720398718; 3720397548; 3720394685; 3720392539; 3720390508; 3720388882; 3720386356; 3720384555; 3720382661; 3720380724; 3720379181; 3720377420; 3720375711; 3720370641; 3720368970; 3720364462; 3720362699; 3720360261 Class II Blood products, collected from a donor whose physical exam was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells 8405574; Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W1170125196435; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced W117008129536J Part 1; W117008129536J Part 2; Class III Blood products, with an unacceptably low red cell recovery rate, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Irradiated W139312000229; Class II Blood product, labeled as leukoreduced, but which had not undergone leukoreduction, was distributed. Beth Israel Medical Center, The Ralph Gore Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W038112245276; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038112265889; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038112261399; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Blood and Blood Products for Reprocessing 42FR80763; 42S64749; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells W036809308115; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036809816399; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF W036809819156; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036809308115; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036812464017; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036812581268; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812845751; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812581268; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036810087981; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF W036810087981; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036810087981; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Irradiated W036811130540; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811130540; W036812426906; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036812426906; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W043212079287; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043212079287; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Cryoprecipitated AHF, Pooled W037711505342; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Hoxworth Blood Center UC Medical Center
Biologics Fresh Frozen Plasma W037712012893; W037711179346; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Hoxworth Blood Center UC Medical Center
Biologics Platelets Pheresis Leukocytes Reduced W036310008862 Part 1; W036310008862 Part 2; Class II Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. BloodCenter of Wisconsin, Inc
Biologics Red Blood Cells Leukocytes Reduced W036309001612; W036309014482; Class II Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed. BloodCenter of Wisconsin, Inc
Biologics Red Blood Cells Leukocytes Reduced W040812117259; Class II Blood product, which wase collected from a donor who traveled to a malarial endemic area, was distributed. West Tennessee Regional Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W270112571961; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W071209008364 Part 1; W071209008364 Part 2; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Red Blood Cells Leukocytes Reduced W071208025659; 9312114; 9468600; 9263803; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Fresh Frozen Plasma 9468600; 9505841; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Red Blood Cells Irradiated 9440117; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Platelets 9440117; 9427804; 9226669; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Red Blood Cells 9505841; 9088034; 9427804; 9226669; 9359488; Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Medic Inc
Biologics Red Blood Cells W086712001888; W086712001971; Class III Blood products, leukodepleted greater than five days after collection, were distributed. ITXM Clinical Services
Food Dried mushrooms sold under the following brand names: 1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 1/2 cup (7g dry) (30g reconstituted) -- Servings Per Container about 4. --- The product is packed on a plastic tray inside a plastic bag. 2) MOUNTAINS brand DRIED MUSHROOM, NET WT: 35G (1.23 OZ) , UPC 6 931653 104064, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 100g -- Servings Per Container 3 --- The product is packed on a plastic tray inside a plastic bag. 1) BEST BEFORE: MAY 3rd, 2013. 2) Best Before: Nov.30, 2013. Class I 1) The product contained undeclared sulfites (7984 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. 2) The product contained undeclared sulfites (7943 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. DZH Import & Export Inc.
Food BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00105 8 Best By 2/16/14 Best By 2/16/14 Class I The firm failed to include allergen milk on the label of this sauce. Buffalo Trace Distillery
Food BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00103 4 Best By 1/30/14 Best By 1/30/14 Class I The firm failed to include allergens of milk and soy on the label of this sauce. Buffalo Trace Distillery
Food BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00107 2 Best By 10/30/14 Beset By 10/30/14 Class I The firm failed to include allergens of wheat and anchovy on the label of this marinade. Soy sauce is listed, but soy is not listed as the source of the sauce. Buffalo Trace Distillery
Food BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00106 5 Best By 1/19/15 Best By 1/19/15 Class I The firm failed to include allergens of soy and anchovy on the label of this sauce. Buffalo Trace Distillery
Food BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00017 4 Best By 11/7/14 Best By 11/7/14 Class I The firm failed to include allergens of soy and anchovy on the labels of this sauce. Buffalo Trace Distillery
Devices Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy. all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap. Class I There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3. Medtronic Neuromodulation
Devices Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis). all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap. Class I There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3. Medtronic Neuromodulation
Drugs Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 Lot# 510122B; exp 04/13 Class III Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. Warner Chilcott Company LLC
Drugs Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880. Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13 Class III Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. Warner Chilcott Company LLC
Drugs Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 Lot# 507694B; exp 02/13 Class III Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. Warner Chilcott Company LLC
Devices Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid. Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012. Class II There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient). B. Braun Medical, Inc.
Devices CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. CS 2100 Class II There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. Carestream Health, Inc.
Devices CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. CS 2200 Class II There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. Carestream Health, Inc.
Devices CareStream Dental Kodak 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. CS 2100 Class II There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. Carestream Health, Inc.
Devices CareStream Dental Kodak 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. CS 2200 Class II There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. Carestream Health, Inc.
Food Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer Lot # 50000114 Best by: 01/2015 Class I Product samples contain DMAA (Methylhexanamine). Nutrex Research, Inc.
Devices SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures Model LR2002 Class II The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece. Discus Dental LLC
Drugs Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8. Lot JZ28, Exp 03/13 Class II CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices. Carib Import & Export, Inc.
Devices Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation. SERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243. Class I When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected. Maquet Cardiovascular Us Sales, Llc
Drugs Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054 16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13, Class III Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine. Reckitt Benckiser Inc
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3. Lot #59824, Exp 04/13 Class II Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. Noven Pharmaceuticals, Inc.
Drugs Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 Lot 15-065-DK, Exp 1SEP2013 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial Hospira Inc.
Drugs Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Lot 17-100-EV and 17-399-EV Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
Drugs Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. Lot # 68864; exp 04/13 Class II Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013. West-ward Pharmaceutical Corp.
Food Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 41322 37813 2; Product Code 37691 Net Wt. 7-oz cartons-UPC Code 0 41322 37691 6; Product Code 32521 and 32522; Net Wt. 44-oz cartons-UPC 0 41322 32521 1; Product Code 37455 Net Wt. 2 lb. cartons-UPC Code 0 41322 37455 4, Market Day, Net Wt.. 22-oz cartons-UPC Code 0 41322 80435 8, Product Code 80435; Schwan's Baked Mozzarella Bites Net Wt.. 22 oz bags- UPC Code 0 72180 61008 9, Product Code 61008, the production date range for these products is 3G1182XXXX - 3G3088XXXX. Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013 Class I Products potentially contaminated with E. coli O121. Rich Products Corp
Food Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268. Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013 Class I Products potentially contaminated with E. coli O121. Rich Products Corp
Food Farm Rich Better For You Pizza Dippers-Pizza Dough made with Whole Wheat Flour and Stuffed with Mozzarella Cheese and Reduced Fat Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 00041322652782, Product Code 65278. Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013 Class I Products potentially contaminated with E. coli O121. Rich Products Corp
Food Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233. Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013 Class I Products potentially contaminated with E. coli O121. Rich Products Corp
Devices Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194 Class II Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button. Masimo Corporation
Devices NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. F023444 Class II Product may be mislabeled. NxStage Medical, Inc.
Devices Vitrea┬« CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion. Versions 6.0 and above. Serial Numbers: VPE0503066 VPE0911551 VPE0908462 324112 VPE0503082 VPE0707078 VPE0707079 5040227558 5040227590 VPE0503081 VPE0609168 5040227140 VPE0707067 VPE1006732 VPE1011765 VPE0707087 5080113685 VPE0802171 VPE0805209 VPE0805281 VPE0902329 475604 5080121211 357678 5080119381 395647 5090112096 449462 VPE1003630 5090102007 VPE0502007 VPE0602118 VPE0602122 VPE0602117 N/A N/A VPE0503073 475635 5090111480 5090111472 5040227329 5031211482 5040919344 VPE0602131  ...
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Class II Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment. Vital Images, Inc.
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. List Numbers: 13000, 13100, 13150 Class I Pump shutting off during use without warning. Hospira Inc.
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. List Numbers: 13086, 13087, 13088 Class I Pump shutting off during use without warning. Hospira Inc.
Devices GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. List Numbers: 13000, 13100, 13150 Class I Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. Hospira Inc.
Devices GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. List Numbers: 13086, 13087, 13088 Class I Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. Hospira Inc.
Devices Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F Class I Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. Newport Medical Instruments Inc
Devices 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. Model/Catalog Number 391-15-708. Lot/Serial Number 59602230. Class II U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled. Encore Medical, Lp
Devices HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Class II Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. Philips Healthcare Inc.
Devices Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X Class II Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient Covidien LLC
Devices Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X Class II Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient Covidien LLC
Drugs Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90 Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014 Class II cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. Jubilant Cadista Pharmaceuticals Inc.
Devices MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand. 01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001;  ...
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Class II Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. GE Healthcare, LLC
Devices Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. 08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001 Class II Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. GE Healthcare, LLC
Devices GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission. Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 00000419280CN3 00000419390CN0 00000419526CN9 00000419525CN1 00000419559CN0 00000418819CN9 00000419506CN1 00000418402CN4 00000419089CN8 00000419550CN9 00000416736CN7 00000418656CN5 00000416781CN3 00000416798CN7 00000418357CN0 00000419447CN8 00000416552CN8 00000418810CN8 00000416764CN9 00000419178CN9 00000417719CN2 00000416389CN5 00000418514CN6 00000417634CN3 00000416848CN0 00000417733CN3 00000417716CN8 00000416849CN8 00000417649CN1 00000416286CN3 00000416401CN8 00000418847CN0 00000419177CN1 00000416533CN8 00000417644CN2 00000419376CN9 00000419504CN6 00000416231CN9 00000416301CN0 00000417626CN9 00000418403CN2 00000419079CN9 00000416268CN1 00000416620CN3 00000416597CN3 00000416763CN1 00000418780CN3 00000417643CN4 00000416647CN6 00000417642CN6 00000418791CN0 00000416466CN1 00000416388CN7 00000416353CN1 00000417134CN4 00000419241CN5 00000418915CN5 00000419174CN8 00000418818CN1 00000416295CN4 00000417720CN0 00000418846CN2 00000416372CN1 00000416762CN3 00000417714CN3 00000416882CN9 00000417713CN5 00000417725CN9 00000416595CN7 00000418020CN4 00000417734CN1 00000419448CN6 00000417735CN8 00000417787CN9 00000419054CN2 00000417696CN2 00000418932CN0 00000419173CN0 00000418300CN0 00000417717CN6 00000418845CN4 00000419561CN6 00000418696CN1 00000418848CN8 00000366477CN8 00000220652HM2 00000421152CN0 00000419040CN1 00000418844CN7 00000416202CN0 00000419391CN8 00000416371CN3 00000418781CN1 00000416814CN2 00000416593CN2 00000416200CN4 00000416739CN1 00000416465CN3 00000416670CN8 00000416881CN1 00000416525CN4 00000416284CN8 00000416796CN1 00000418943CN7 00000419039CN3 Class II Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. GE Healthcare, LLC
Food Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286 expiration date 5/17/13, Lot# 13081 Class I Wegmans Foods Markets issued a Press Release on April 16, 2013 and is recalling affected units of Roasted Red Pepper Dip because some of the tubs may have an incorrect ingredient label that does not list milk and eggs. Wegmans Food Markets
Devices GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294098MR9 00000294280MR3 00000294472MR6 00000294494MR0 00000294556MR6 00000294576MR4 00000294643MR2 00000294665MR5 00000294718MR2 00000294913MR9 00000294953MR5 00000295024MR4 00000295092MR1 00000295112MR7 00000295134MR1 00000295215MR8 00000295228MR1 00000295241MR4 00000295506MR0 00000295904MR7 00000296014MR4 00000296046MR6 00000296070MR6 00000296096MR1 00000296097MR9 00000296171MR2 00000296226MR0  ...
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Class II GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present. GE Healthcare, LLC
Devices GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device. Mfg Lot or Serial # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2  ...
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Class II GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present. GE Healthcare, LLC
Devices GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device. Mfg Lot or Serial # 284481HM9 283390HM3 282416HM7 300218HM5 296431HM0 294361HM1 296436HM9 278690HM3 285914HM8 300212HM8 302728HM1 286892HM5 294373HM6 284475HM1 274212HM0 294150HM8 286871HM9 285458HM6 285464HM4 285905HM6 286889HM1 289113HM3 290003HM3 290018HM1 295187HM9 295708HM2 297795HM7 298512HM5 298518HM2 300206HM0 300209HM4 300905HM7 300911HM5 305123HM2 305132HM3 305141HM4 305300HM6 305303HM0 306320HM3 307364HM0 307373HM1 307376HM4 308186HM6 308923HM2 309476HM0  ...
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Class II GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present. GE Healthcare, LLC
Devices MediChoice┬« Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. Item # Lot# WOD5001 1206DG13A WOD5001 1206DG13B WOD5001 1207DG13A WOD5001 1208DG13A WOD5001 1209DG13A WOD5001 1210DG13A/B WOD5001 1211DG13A WOD5001 1212DG13A WOD5001 1301DG13A WOD5001 1303DG13A WOD5002 1206DG14A WOD5002 1208DG14A WOD5002 1209DG14A WOD5002 1211DG14A Expiration Dates: 2017-05,  ...
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Class II Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use. Owens & Minor Distribution, Inc.
Devices Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve." Catalog number 703615 Class II Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended. Stryker Howmedica Osteonics Corp.
Devices Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754 Class II Software update to fix multiple safety related issues. Siemens Medical Solutions USA, Inc
Food Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids UPC Code 8 94163 00220 5 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Spicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Guava Fruit Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, guava fruit, sugar, tumeric, blue 1, UPC Code 8 94163 00210 6 firm does not code products Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6 firm does not code products Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Pina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder, firm does not code product Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Strawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40, UPC Code 8 94163 00220 5 firm does not code product Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Bubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6 firm does not code products Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Strawberry Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6 firm does not code products Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Strawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4 firm does not code products Class III Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Food Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5 firm does not code products Class II Product labeling is incorrect, FD&C colors are undeclared. Paleteria Y Neveria La Rosita, LLC
Veterinary Amoxicillin Capsules, USP, 500mg, 500 count bottles, NDC 26637-222-50. Lot CS2959, Expiry 07-2015, NDC 26637-222-50. Class II Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500mg due to potential contamination with fragments of stainless steel wire mesh. Sandoz Incorporated
Drugs "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015. Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz) Class II Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination. Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Devices STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Lot Codes: 025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 038127 039127 040127 041121 042127 043127 044127 045121 046127 047127 048127 049127 052127 053121 053127 054127 055121 056127 057127 058127 059127 060127 061127 062121 062127 063127 064127 065127 067127 068127 069121 070127 071127 072127 073127 076121 081127 082127 084127 085127 086121 086127 087127 089127 090127 091127 092127 093121 094127 095127 100121 100127 101127 102127 104127 107121 107127 107128 109127 109128 110127 111127 114121 118127 121121 121127 122127 123127 124127 125127 128121 128127 129127 130127 131127 132127 135121 135127 136127 137127 156121 156127 158127 159127 160127 163121 163127 164127 165127 13912706 18112706 18412706 18512706 18712706 18812706 19012706 19212706 19312706 19412706 19512706 19712706 19812106 19912706 20012106 20112706 20212706 20512106 20512706 20612106 20612706 20712706 20812106 20812706 21212106 21212706 21312106 21312706 21412706 21512106 21512806 21612106 21812706 21912706 22012106 22112706 22212706 22312706 22612106 22612706 22712706 22812106 22812706 22912706 23012106 23012706 23112706 23312106 23312706 23412706 23512106 23512706 23612706 23712106 23712706 23812706 24012106 24012706 24112706 24212106 24212706 24312706 24412706 24812106 24812706 24912106 24912706 25012706 25112706 25412106 25412706 25512106 25512706 25612106 25812106 25812706 25912706 26112106 26212706 26312106 26312706 26812106 26812706 30112706 Class II Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life. Advanced Sterilization Products
Drugs Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD. Lot # 6IHD, Exp 09/30/2013 Class III Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form. Physicians Total Care, Inc.
Drugs Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1. Lot #: 610593, Exp 06/13 Class III Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. Hi-Tech Pharmacal Co., Inc.
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