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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 011GF47386 Class II Blood product, manufactured from a unit of whole blood lacking hematocrit documentation, was distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 6519597; 6519597 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 6032691; 6032687; 6032679; 6032689; 6519587 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced 9917207 Class II Blood product, which did not meet acceptable product specifications, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells (Apheresis) 01FH11831, 01FH13343, 01KK20799, 01KK22605, 01KK23536, 01KM37179, 01KX97207, 01Q92728 Class II Blood products, which did not meet the minimum requirement for total hemoglobin, were distributed. American National Red Cross (The)
Biologics Red Blood Cells LX28135 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced 01FP43191 Class II Blood product, which did not meet acceptable product specifications, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 021LL14609. Class II Blood product, collected from a donor who lived in a country endemic for malaria, was distributed. . American National Red Cross
Biologics Red Blood Cells LT37295 Class II Blood product, positive for the JKb-antigen but labeled as JKb-antigen negative, was distributed. LifeServe Blood Center
Biologics Red Blood Cells LC83075 Class II Blood product, positive for the E-antigen but labeled as E-antigen negative, was distributed. LifeServe Blood Center
Biologics Platelets 01Q99477;01Q99514 Class II Blood products, possibly contaminated with air during collection, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01Q99451; 01Q99454; 01Q99477; 01Q99489; 01Q99497; 01Q99519; 01Q99522; 01Q99528; 01Q99531; 01Q99548; 01Q99552 Class II Blood products, possibly contaminated with air during collection, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 01Q99451;01Q99454;01Q99497 Class II Blood products, possibly contaminated with air during collection, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 01Q99487;01Q99492 Class II Blood products, possibly contaminated with air during collection, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced P40172 Part A ; P40172 Part B Class II Blood products, for which the required quality control testing was not performed, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced LE99344 Class II Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed. LifeServe Blood Center
Biologics Red Blood Cells 6798040 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6819346 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 21LY18474 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 7764846;7764844 Class III Blood products, which were exposed to unacceptable temperature during storage, were distributed. New York Blood Center, Inc.
Biologics Source Plasma 0530052514, 0530052215, 0530050895, 0530050580, 0530047198, 0530046819, 0530046556, 0530046177, 0530045908, 0530045575, 0530045209, 0530044864, 0530044645, 0530044165, 0530043843, 0530043544, 0530043221, 0530042952, 0530042614, 0530042283, 0530041970, 0530041692, 0530041301, 0530040953, 0530040591, 0530040201, 0530040019, 0530039491, 0530039298, 0530038835, 0530038580, 0530038196, 0530037947, 0530037640, 0530037395, 0530037079, 0530036854, 0530036272, 0530035763, 0530035112, 0530034619, 0530034010, 0530033447, 0530031462, 0530031138, 0530030785, 0530030640, 0530030316, 0530029897, 0530029726,  ...
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Class III Blood products, collected from a donor who was previously deferred, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced 42FE10146; 42FG38598; 42L54257; 42GX05663; 42GS32747; 42FE10012; 42FE10015; 42FE10144; 42FE10145; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 42FY87647; 42GX05665; 42L54010; 42L54256; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006LH17884; 006GT77083; 006GE34211; 006LV50477; 006LP45421; 006LQ04192; 006LV50512; 006LV50488; 006LV50506; 006LH17880; 006LY83121; 006LY83089; 006LY83117; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 006FY92834; 006FC59395; 42FW52035; 42FG38596; 42FG38597;42M35638; 42GT24395; 42GS33656; 42GM06234; 42GM06237; 42GM06238;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 42FE10144; 42FG38596; 42GX05663; 42CX05665; 42L54010 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 42FG38734 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Cryoprecipitate AHF, Pooled 006L16589 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 006FE32995 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours after Phlebotomy (FP24) 42FZ62526; 42FG38596; 42FZ31978; 006LV50504; 006LV50477; 006LH16787; 006FY92533; 006LT83833; 006FY93230; 006GV77545; 006GE03248; 006FC59791; 006FC59790; 006GX88824; 006GX88853; 006FE31590; 006FE31591; 006GX88583; 006FR07331; 006FR07309; 006FY91374; 006GX88558; 006FY91468; 006LT84124; 006FY91564; 006FY83209; 006LS18607; 006GP95732; 006FE32997; 006FC60183; 006LH16761; 006LQ04205; 006LT84139; 006FY92525; 006FR07284; 006GT77323; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91322;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Food Granulated Peanuts in 1 lb plastic bags. Lot #'s 8148B, 8168B, 8288B & 8289B Class I The product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella. Tropical Nut & Fruit Inc
Food B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0 No code. Class I Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella BA Sweetie Candy Co
Food B. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2. No code. Class I Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella BA Sweetie Candy Co
Food Sugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9 All codes. Class I Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella BA Sweetie Candy Co
Food Sweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6 No code. Class I Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella BA Sweetie Candy Co
Food Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831 Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831 Class I This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella Giannios Candy Co Inc
Food Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags Sweet Sentiments: UPC-765915043329, 765915043534; Code date-09 AL 19, 09 AL 21, Gorant: UPC-765915043299, 765915017832, 765915047433, 765915046788, 765915047693; Code date-08 NO 23, 09 DE 15, 09 DE 16, 07 OC 17, 09 MA 30 Class I The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella. Gorant Candies Inc A Division of Carlton Cards Retail Inc
Food Milk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags Sweet Sentiments: UPC-765915043367, 765915043527; Code date: 09 AL 21, Gorant: UPC-765915043282, 765915043435, 765915047457, 765915047709, 765915045125, 765915046771; Code Date: 09 MA 30, 09 AL 15, 09 MA 25, Class I The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella. Gorant Candies Inc A Division of Carlton Cards Retail Inc
Food No Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags 765915026179, 765915043773, 765915047549, 765915047594. Date code: 09 AU 12, 09 DE 12, 11-15-08, Class I The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella. Gorant Candies Inc A Division of Carlton Cards Retail Inc
Food No Sugar Added Bridge Mix in 12 oz bags UPC: 765915026209, 765915047624. Date code: 09 DE 01. Class I The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella. Gorant Candies Inc A Division of Carlton Cards Retail Inc
Biologics Source Plasma 373106290, 373104952, 373102292, 373102227, 373104387, 373104046, 373103311, 373102963, 373102890, 3730023031, 3730022006, 3730021677, 3730020460, 3730019561, 3730019017, 3730017436, 3730016875, 3730015939, 3730015373, 3730014412, 3730013862, 3730012982, 3730012426, 3730011573, 3730011013, 3730010120, 3730009612, 3730008740, 3730008225, 3730007384, 3730006905, 3730006156, 3730005611, 3730004822, 3730004371, 3730003622, 3730003176, 3730002480, 3730002082, 3730001426, 3730001049, 3730000460, 3730000141, 373124259, 373123856, 373123171, 373122728, 373122071, 373121753, 373120437,  ...
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Class II Blood products, collected from donors who did not have a complete physical exam, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 05500078721, 0550884624, 0550880694, 0550878282, 0550877802, 0550876130, 0550874472, 0550872589, 0550869379, 0550866855, 0550866106, 0550865200, 0550864090, 0550862725, 0550862005, 0550860313, 0550859462, 0550857143, 0550856245, 0550855001, 0550854403, 0550852476, 0550850598, 0550850013, 0550848572, 0550848061, 0550846449, 0550844814, 0550843807, 0550842770, 0550840117, 0550838522, 0550837750, 0550836435, 0550834107, 0550832459, 0550829940, 0550828624, 0550827749, 0550826098, 0550825574, 0550823940, 0550823081, 0550821608, 0550819697, 0550819061. Class III Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Food Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101 Manufacture dates from 09/19/2011 through 10/19/2011 and all expiration dates between 10/19/2011 and 11/19/2011. Class II During an FDA inspection at the firm, it was discovered that the firm uses, FD&C Yellow #5, in the manufacture of their tortillas. However, FD&C Yellow #5 is not listed in the ingredient statement. Tortilleria Provincia
Biologics Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL 5 mL sample PRODUCT CODE S3905 LOT NUMBERS Q02F010, Q05F120, Q19F420, Q35F780, Q33F700 1 mL PRODUCT CODE 3901 LOT NUMBERS Q44F97K, Q53F350 2 mL PRODUCT CODE 3902 LOT NUMBERS Q03F030, Q09F310, Q29F610, Q44F980, Q31F640, Q35F750, Q36F820, Q46F040, Q47F050 5 mL PRODUCT CODE 3905 LOT NUMBERS P44F050 P45F100 P45F090 P46F120 P48F180 R06F130  ...
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Class III Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. Ethicon, Inc.
Biologics Thrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05 Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J Class III Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. Ethicon, Inc.
Drugs HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54 Lot # 10-199-JT Exp. 10/13 Class II Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. Hospira Inc.
Biologics Red Blood Cells W035412060950 Class II Blood product, collected from a donor who had a previous history of travel to a malarial endemic area, was distributed. Community Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W1151122758236- part 1; W1151122758236- part 2 Class II Blood products, which were not quarantined subsequent to receiving post donation illness information, were distributed. LifeSouth Community Blood Centers Inc
Biologics Platelets Pheresis Leukocytes Reduced W115112327021R Class II Blood product, labeled leukoreduced but was not tested to verify the White Blood Cell count, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115112282932C Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112277608P- part 1; W115112277608P-part 2 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115112277116S Class II Platelet, with a low platelet count, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W137512105036; W137512107334 Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells 2533388 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 2533388 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 W010712004910; Class II D. D. Eisenhower Army Med. Ctr. - Blood Bank
Biologics Blood and Blood Products for Reprocessing W010712004910 Class II Blood products, collected from a donor considered to be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. D. D. Eisenhower Army Med. Ctr. - Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W036811258578 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 W036811258578; W036810173369 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 W036810173369 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.
Devices Philips Digital Diagnost Stationary radiographic system All Digital Diagnost systems with Eleva software version 3.0.x Class II When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image. Philips Healthcare Inc.
Drugs ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 2E69023A, Exp. FEB 28 2015 Class II CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed. Bristol Myers Squibb Manufacturing Company
Devices Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. All serial numbers / Multiple manufacture dates. Part# Item# ================ A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06 Class II Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result. Beckman Coulter Inc.
Drugs 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23, Lot Number 02-117-JT Exp. 02/13 Class II Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal. Hospira Inc.
Devices BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing. Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots Class III BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints. Becton Dickinson & Company
Devices GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning. 000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS  ...
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Class II Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis. GE Healthcare, LLC
Drugs a)60 tablets NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 69877A; 68977B; 68978B; 6978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013 Class II Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. West-ward Pharmaceutical Corp.
Devices Macro Micro Subdural Electrode Product Usage: The AD-TECH Subdural Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. REF numbers (catalog numbers): EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000,  ...
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Class I The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Ad-Tech Medical Instrument Corporation
Devices Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening. Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090. Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Synthes USA HQ, Inc.
Devices Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening. Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336. Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Synthes USA HQ, Inc.
Devices Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening. Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466 Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Synthes USA HQ, Inc.
Biologics Cornea 0801006COS, 0801006COD, 0801016COD, 0801016COS, 0801020COD, 0801022COS, 0801022COD, 0802009COSG2, 0802009COD, 0802009COSG1, 0802015COD, 0802015COSGPC, 0802015COS, 0802023COD, 0802023COS, 0802060COS, 0802060COD, 0802076COD, 0802076COS, 0802080CODG2, 0802080CODG1, 0802080COSG1, 0802080COSG2, 0802084COSG1, 0802084COSG2, 0802084CODG1, 0802084CODG2, 0803007COS, 0803007COD, 0803011COD, 0803011COS, 0803025COS, 0803025COD, 0803025COSGPC, 0803058COD, 0803076CODG1, 0803076CODG2, 0803076COSG2, 0803076COSG1, 0804015COD, 0804015COS, 0804042COD, 0805019COSG2, 0805019COSG1, 0805019COD, 0805056COS, 0805056COD, 0805056COSGPC, 0805064COD, 0805064COS,  ...
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Class III Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Devices SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. All codes/units of ARTISTE model. Class II Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment. Siemens Medical Solutions USA, Inc
Food Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW" 7425A2297A, 7425A2298A and 7425A2298B Class I A surveillance sample was found positive for Listeria monocytogenes. Ocean Beauty Seafoods, LLC
Food Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110 All codes distributed between 1/1/2011 and 1/24/2013 Class II Z Pro High Protein Vanilla Flavor Supplement is under recall because it contains the allergens milk and coconut, a tree nut, which are not declared on the label of the individual packets of the product. R-Kane Products Inc.
Food Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110 All codes distributed between 1/1/2011 and 1/24/2013 Class II Z Pro High Protein Chocolate Flavor Supplement is under recall since it contains milk and soy, allergens, which are not declared on the label of the individual packets of the product. R-Kane Products Inc.
Devices Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Model 728260, Serial #, 3467,5610,6151,6204,6209,6221,6437,6483,6543,6636,6658,6717,6788,6865,7154,7186,7253,7470, 7507,7576,7579,7639,7690,7692,7708,7835,7977,8099,8255,8332,8443,8756,8757,8890,8922,9079, 9201,9395,9422,10085,10086,10090,10102,10138,10155,10180,10197,10216,10240,10261,10264,10271, 10312, 10324,10328,10346,10355,10359,10378,10383,10389,10422,10427,10431,10435,10437,10442, 10455,10456,10470,10476,10492,10537,10547,10561,10584,10598,10604,10606,10622,10630,10646, 10672,10686,10699,10722,10727,10738,10745,10747,10770,10776,10778,10796,10798,10817,10821, 10822,10823,10838,10841,10874,10889,10890,10897,10952,10953,10965,10980,10985,10988,10998, 11007,11010,11025,11036,11037,11043,11051,11054,11058,11062,11065,11080,11083,11085,11086, 11088,11089,11105,11107,11113,11121,11127,11128,11140,11141,11147,11148,11149,11151,11152, 11153,11166,11169,11173,11174,11208,11221,11230,11232,11241,11243,11260,11262,11267,11274, 11278,11280,11282,11291,11314,11317,11324,11334,11339,11341,11557,11561,11564,11567,11572, 11577,11581,11585,11603,11610,11612,11620,11622,11630,11631,11633,11644,11649,11650,11656, 11657,11659,11660,11662,11663,11667,11668,11670,11673,11674,11684,11685,11692,11694,11696, 11699,11700,11703,11706,11708,11711,11714,11717,11718,11720,11729,11739,11740,11742,11743, 11744,11745,11747,11748,11749,11750,11751,11753,11754,11755,11756,11758,11760,11762,11765, 11766,11768,11769,11770,11772,11773,11774,11776,11779,11780,11781,11782,11784,11785,11788, 11790,11791,11793,11794,11795,11796,11797,11798,11800,11801,11802,11803,11804,11805,11806, 11807,11808,11809,11810,11812,11813,11814,11816,11817,11818,11819,11822,11823,11830,11831, 11832,11833,11834,11838,11839,11840,11841,11842,11843,11844,11845,11846,11847,11848,11850, 11851,11852,11854,11856,11858,11859,11862,11863,11864,11865,11866,11868,11869,11870,11873, 11874,11877,11878,11879,11880,11881,11882,11883,11884,11885,11886,11888,11889,11890,11891, 11892,11893,11896,11897,11898,11899,11900,11901,11902,11903,11904,11905,11906,11907,11911, 11912,11913,11916,11917,11918,11920,11923,11925,11927,11928,11929,11930,11932,11933,11934, 11935,11936,11937,11938,11939,11942,11943,11944,11947,11976,11977,11978,11979,11980,12049, 12051,12100,12100,12102,12103,12104,12105,12106,12107,12108,12109,12110,12111,12112,12115, 12117,12118,12119,12120,12121,12122,12123,12124,12125,12126,12128,12129,12130,12132,12133, 12136,12138,12139,12140,12141,12142,12144,12145,12146,12147,12152,12154,12155,12157,12158, 12159,12160,12162,12163,12164,12167,12170,12171,12172,12173,12174,12175,12176,12178,12179, 12180,12181,12182,12183,12200,12201,12202,12203,12204,12205,12206,12207,12208,12209,12210, 12211,12215,12216,12217,12218,12219,12220,12222,12223,12224,12225,12226,12227,12228,12229, 12230,12231,12236,12237,12239,12240,12241,12242,12243,12244,12248,12249,12250,12271,12273, 12274,12302,12303,12304,12305,12306,12309,12310,12311,12312,12314,12315,12316,12317,12318, 12321,12322,12323,12324,12325,12326,12327,12328,12329,12330,12331,12332,12333,12336,12337, 12338,12339,12341,12342,12343,12345,12346,12347,12348,12349,12350,12351,12352,12353,12354, 12355,12356,12357,12359,12360,12362,12363,12364,12366,12369,12370,12373,12376,12377,12379, 12380,12382,12383,12386,12388,12389,12391,12392,12394,12396,12397,12398,12399,12400,12403, 12405,12406,12407,12408,12409,12410,12411,12412,12413,12414,12415,12416,12417,12418,12419, 12420,12421,12422,12423,12424,12425,12428,12429,12430,12431,12432,12434,12435,12436,12438, 12439,12440,12441,12443,12444,12445,12446,12447,12471,12472,12473,12474,12475,12476,12477, 12492,12493,12494,12495,12496,12497,12498,12500,12501,12503,12504,12505,12508,12510,12513, 12514,12516,12517,12521,12522,12526,12527,12528,12530,12531,12538,12539,12541,12542,12543, 12544,12545,12546,12547,12548,12549,12550,12551,12552,12553,12554,12555,12556,12557,12558, 12559,12561,12562,12563,12565,12567,12568,12569,12570,12573,12574,12575,12577,12579,12580, 12581,12583,12584,12586,12587,12588,12589,12591,12592,12594,12595,12596,12597,12598,12601, 12602,12603,12604,12605,12606,12611,12612,12614,12617,12618,12619,12620,12621,12622,12623,  ...
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Class II Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances. Philips Medical Systems (Cleveland) Inc
Food UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz.. Batch #911 Class I Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes. Mkg Provisions Inc
Food UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed Batch #911 Class I Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes. Mkg Provisions Inc
Food Cold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed Batch #1478-69441 Class I Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes. Mkg Provisions Inc
Food Cold Smoke Atlantic Salmon Trimmings Vacuum Packed Batch #1478-69441 and #911 Class I Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes. Mkg Provisions Inc
Food Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083 UPC 011433111201 Class II Unapproved dye in product (Rhodamine B - Basic Violet 10). Deep Foods Inc
Drugs Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08 Lot# 80798; FP-49-081-14870 Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. Aaron Industries Inc
Drugs Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011 Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307 Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. Aaron Industries Inc
Drugs Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA. Lot# 71648, 68088; FP-47-041-02535 Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. Aaron Industries Inc
Drugs Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712. Lot# 81198, 82183, 80797; FP-44-081-03884 Class III Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. Aaron Industries Inc
Drugs Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430. 02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14 Class III Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA). Glenmark Generics Inc., USA
Devices PROXIMATE® Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures. Expiration dates: September 2012 - August 2017 Class II Ethicon Endo-Surgery initiated a voluntary recall for all PSX Proximate® Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device. Ethicon Endo-Surgery Inc
Devices D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone Model #D3000 Class III The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. Linvatec Corp. dba ConMed Linvatec
Devices D3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone Model #D3000I Class III The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. Linvatec Corp. dba ConMed Linvatec
Food Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids. The item code numbers are 71400 and 71410 with lot numbers from 010111 through 021313. Class I DeCoty Coffee Company of San Angelo, Texas is recalling its 1.25lb and 5.75lb of DeCoty Taco Seasoning because it contains an undeclared ingredient, Soy. People who have an allergy or severe sensitivity to Soy run the risk of a life threatening or serious allergic reaction if they consume these items. Decoty Coffee Company, Inc
Devices Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144. Class II Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations. Salyer Prn Biomedical
Food ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store bakeries and food service customers. Product produced from July 27, 2012 through February 1, 2013 (Julian Dates 77002209 - 77003302) Class II Product was manufactured with bulk flour supplied by Dakota Specialty Milling which is being recalled due to reports of metal fragments.. Rich Products Corp
Food Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray. Production Date Green Bag Clip Code 7/24/12 G01206Gxx* 8/1/12 G01214Gxx* 8/6/12 G01219Gxx* 8/30/12 G01243Gxx* 9/26/12 G01270Gxx* 10/17/12 G01291Gxx* 11/28/12 G01333Gxx* 12/16/12 G01351Gxx* 12/31/12 G01366Gxx* 1/18/13 G01018Gxx* (*xx denotes the hour of production and will be represented by two numeric digits (e.g. 09 would mean 9:00 a.m. production hour). Class II The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen. Rich Products Corp
Food Daphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case Production Date Bag Clip Code Case Jet Code 09/06/2012 09/06/12 09/06/12 L1 HH:MM 11/13/2012 11/13/12 11/13/12 L1 HH:MM 01/20/2013 01/20/13 01/20/13 L1 HH:MM *HH:MM denotes the hour and minute of production and will be represented by four numeric digits (e.g. 09:20 would mean 9:20 a.m. time of production) Class II The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen. Rich Products Corp
Devices Atricure Inc. The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. Model Number(s): MAX1 A000163, Lot Number 41865 Class II AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. Atricure Inc
Devices Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331. Model Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO  ...
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Class II Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. Medtronic Inc. Cardiac Rhythm Disease Management
Food HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet; Lot #'s 133405G10; 133407G10; 133407C10; 133408C10; 133408G10; 133409C10; 133409G10; 133411L10; 133410L10; 133410J10;133412L10; 133410M11; 133410K07; 133411M11; 133412M11; 133418R10; Catalogue #2797; NNPart #'s: 68-00033; 68-00037; 68-00032; 68-00031; 68-00092. Class I Herbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen. Herbalife International Of America Inc
Devices Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. Lot numbers: HUWI1379 and HUWI1380. Class II Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. Bard Access Systems
Devices Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. Lot numbers: HUWI1379 and HUWI1380. Class II Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. Bard Access Systems
Devices AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. AMSCO C: Serial Numbers: 021911201  023461202 AMSCO 400: Serial Numbers: 030181215-030291310 Class II The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance. Steris Corporation
Food Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077 UPC: 036800292208 GES 462449, Best Before Date: 12/03/2016 Class I Undeclared soy and wheat: One can of product labeled as containing red enchilada sauce, was found to contain green enchilada sauce which contains wheat and soy. Bruce Foods Corp
Devices Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports. Lot #1210099 Class II The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. Churchill Medical Systems, Inc.
Drugs Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11. Lot #: 50077231 Class III Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. Actavis Elizabeth LLC
Drugs Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13 Class II CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. RX South LLC DBA RX3 Pharmacy
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