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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. all serial numbers Class II An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath General Electric Med Systems LLC
Devices GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use. All serial numbers Class II An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath General Electric Med Systems LLC
Devices GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. All serial numbers Class II An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath General Electric Med Systems LLC
Biologics Red Blood Cells Leukocytes Reduced 084FT81025 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Source Plasma 0300101489, 0300100390, 0300099622, 0300098831, 0300098638, 0300098192 Class III Blood products collected from a donor who was permanently deferred for unsuitable test results, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced GF57913 Class III Blood product, collected from a donor whose hematocrit was not recorded during donor screening, was distributed. Sacramento Medical Foundation
Biologics Red Blood Cells Leukocytes Reduced 006GE11777; 006GE11778; 006GE11749; 006GE11751; 006GE11740; 006GE11742; 006GE11781; 006GE11783; 006GE11790; 006GK32635; 006GK32636; 006GV41388; 006GK32645; 006GK32637; 006GE11792; 006GE11743; 006GE11784; 006GE11744; 006GE11747; 006GE11793; 006GE11791; 006GK32623; 006GE11794; 006GE11800; Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 006GK31728; 006LP10318 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 006LP10318 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 24KJ00124;24KK03602;24KK03603;24KK03605;24KZ56690;24KK03606;24KK03611;24KK03612 Class III Blood product, collected from an ineligible donor, was distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced W045007912888 (split product) Class II Blood products, possibly contaminated with Propionibacterium species, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 50KC04830;50KC04830 Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis W021608000071 Class II Blood product, for which the Viral testing was not performed, was distributed. Department of the Navy
Biologics Source Plasma Date range: 03/19/2008 - 07/20/2009 4080364443 4080363688 4080362157 4080360178 4080359825 4080357806 4080353533 4080350379 4080332278 4080330772 4080330031 4080322922 4080291696 4080289640 4080284174 4080282498 4080280450 4080272644 4080272049 4080266378 4080264124 4080263652 4080260090 4080247540 4080246828 4080245487 4080244786 4080243413 4080241829 4080241323 4080239819 4080239326 4080237977 4080237292 4080235880 4080235289 4080233975 4080233403 4080231973 4080231300 4080229657 4080229072 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. CSL Plasma, Inc.
Biologics Source Plasma Date range: 01/25/2009 - 09/13/2009 4080377254 4080376227 4080375198 4080374875 4080371826 4080368237 4080364435 4080362201 4080361675 4080359977 4080356133 4080355757 4080354062 4080353483 4080345602 4080344801 4080342452 4080338594 4080337252 4080336327 4080324021 4080322220 4080316443 4080314989 4080313462 4080377829 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma Date range: 06/09/2008 - 10/22/2008 4080290194 4080286373 4080284560 4080283050 4080254232 4080252589 4080252051, 4080292029 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. CSL Plasma, Inc.
Biologics Source Plasma Date Range: 01/15/2009 - 10/23/2009 4010493230 4010491309 4010488647 4010487878 4010486017 4010485031 4010483309 4010482378 4010472783 4010471427 4010470171 4010468531 4010467035 4010465518 4010464126 4010462434 4010461392 4010459651 4010458060 4010456457 4010455043 4010452284 4010450809 4010449176 4010447721 4010446269 4010444903 4010442931 4010441553 4010439623 4010438101 4010436074 4010434782 4010432920 4010431615 4010429513 4010428243 4010426203 4010424871 4010423157 4010421234 4010420107 4010418059 4010416671 4010414707  ...
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Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 3910082101; 3910082598; 3910082906; 3910085911; 3910086807; 3910081900; 3910081503; 3910081868; 3910082275; 3910082774; 3910083156; 3910083903; 3910084951; 3910085815; 3910086223; 3910080955; 3910081305; 3910081712; 3910082232; 3910082762; 3910083137; 3910083887; 3910084221; 3910084617; 3910084939; 3910085447; 3910085791; 3910086679; 3910047776; 3910043408; 3910042108; 3910038442; 3910037785; 3910037362; 3910036416; 3910035164; 3910034679; 3910032818; 3910029232; 3910028845; 3910027896; 3910027430; 3910026492; 3910024632; 3910023541; 3910022087; 3910021589; 3910020014; 3910018908; 3910018439; 3910017446; 3910017013; 3910015987;  ...
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Class II Blood products, collected from a donor whose routine physical examination was inadequately performed, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 6840061;6840061 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. LifeShare Community Blood Services
Food Country Fresh Ovens Cheese Coffee Cake, Net Wt 5 oz (142g). Dist. by Country Fresh Ovens, St. Paul Park, MN 55071 Unknown Class II Recent label audits show that the Country Fresh Ovens Cheese Coffee Cake contain an undeclared allergen, milk. Super Mom's
Drugs CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967. 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058 Class II Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. Luitpold Pharmaceuticals, Inc.
Food better batter brand Gluten Free Pancake & Biscuit Mix packaged in chip board box, in 20 oz. (UPC 8 96439 00207 0) and in 2.5 lb sizes (UPC 8 96439 00203 2). The 20 oz. product is labeled in part, "*** better batter PANCAKE & BISCUIT MIX *** 20 OZ *** UPC 8 96439 00207 0***". The 2.5 lb. product is labeled in part, "*** better batter gluten free pancake/biscuit mix *** 2.5 lb ***. 20 oz. product: Best Before Dates of 27 July 2012, 25 October 2012, 23 December 2012, 28 December 2012, and 28 March 2013; 2.5 lb. product: Best Before Dates of 04 December 2011, 26 February 2012, 17 March 2012, 14 June 2012, 11 August 2012, and 03 March 2013. Class I The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil. Raymond Hadley Corporation
Food better batter brand YELLOW CAKE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz. (517 g), UPC 8 96439 00210 0. The mix is packaged in a chip board box. Best Before Dates of 26 January 2013, 28 February 2013, 01 March 2013, 29 March 2013. Class I The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil. Raymond Hadley Corporation
Food better batter brand CHOCOLATE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz (517 g), UPC 8 96439 00209 4. The mix is packaged in a chip board box. Best Before Dates of 28 January 2013, 28 February 2013, and 30 March 2013 Class I The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil. Raymond Hadley Corporation
Food #1 Gluten Free brand Chocolate Cake Mix, Net Wt: 5 lb., UPC 6 54367 43530 4 Lot 33310-4 Class I The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil. Raymond Hadley Corporation
Food #1 Gluten Free brand White Cake Mix, 5 lb., UPC 6 54367 43505 2. Lot 33310-4 Class I The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil. Raymond Hadley Corporation
Veterinary Payback Kountry Buffet 14% Text, packaged in 50-lb. bags. The firm name on the label says the product is Manufactured by CHS Nutrition, Sioux Falls, SD. Lot #M718430 and Lot #M720280 Class I The nonmedicated feed is contaminated with monensin Western Feed LLC
Devices Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+;  ...
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Class II During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem. Aesculap Implant Systems
Devices Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug. Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700010, 700012, 700013, 700014, 700017, 700018, 700020, 700021, 700022, 700023, 700024, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700037, 700038, 700039, 700040, 700041, 700042, 700043, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700053, 700054,  ...
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Class I Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010. Sigma
Drugs DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070 Lot 022110-01 Class III Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level. Quadrant Chemical Corporation
Food 1) Crispy Pistachio Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 200g/7oz***TWI FOODS INC***1869 Cage Court, Mississauga, ON Canada L5S 1S3. 1-866-9-CRISPY*** ; 2) Crispy Pistachio Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 400g/14oz***www.CrispyJustBaked.com***Ingredients: Wheat flour, soybean oil margarine, sugar, pista, cornstarch, (vegetable based soy lecithin and soy protein), corn syrup, baking powder, artificial flavor, salt, and ammonium carbonate.***6 27265 00161 2***" All Lots All Codes with expiration date up to 03/27/2013. Class I House of Spices (India) Inc., Orlando, FL is recalling 7 oz packages of Crispy Coconut Cookies, Crispy Almond Cookies, 7oz and 14 oz Crispy Pistachio Cookies manufactured by TWI Foods Inc. Ontario Canada. The products may contain undeclared milk and almonds. House of Spices (India) Inc.
Food Crispy Coconut Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***COCONUT COOKIES***Just Baked!***Biscuit noix de coco***Manufactured by: ***www.crispyjustbaked.com***TWI FOODS INC***2600 Drew Road, Mississauga, ON Canada L4T 3M5 1-866-9-CRISPY***Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, corn starch, dessicated coconut, vegetable based soy protein, corn syrup, artificial flavor, salt, ammonium carbonate.***PRODUCT OF CANADA***6 27265 00521 4***Net Wt./Poids Net 200g/0.44 lb(7.0 oz)***" All Lots All Codes with expiration date up to 03/27/2013. Class I House of Spices (India) Inc., Orlando, FL is recalling 7 oz packages of Crispy Coconut Cookies, Crispy Almond Cookies, 7oz and 14 oz Crispy Pistachio Cookies manufactured by TWI Foods Inc. Ontario Canada. The product may contain undeclared milk. House of Spices (India) Inc.
Food Crispy Almond Cookie product is labeled in part: "***VEGETARIAN***NO EGG*** CRISPY***By TWI Foods***ALMOND COOKIES***Just Baked!***BISCUIT ALMANDE***Manufactured by***www.crispyjustbaked.com***TWI FOODS INC. 2600 Drew Road, Mississauga, On Canada. L4T 3M5 1-866-9-CRISPY***Ingredients: Wheat flour, soybean oil margarine, sugar, yellow corn flour, cornstarch, almond, vegetable based soy protein, corn syrup, artificial flavor, salt and ammonium carbonate.***Net Wt./Poids Net 200g/0.44 lb(7 oz)***PRODUCT OF CANADA***6 27265 00522 1***" All Lots All Codes with expiration date up to 03/27/2013. Class I House of Spices (India) Inc., Orlando, FL is recalling 7 oz packages of Crispy Coconut Cookies, Crispy Almond Cookies, 7oz and 14 oz Crispy Pistachio Cookies manufactured by TWI Foods Inc. Ontario Canada. The product may contain undeclared milk. House of Spices (India) Inc.
Food Liquid Peanut Butter Topping under the Brand name: Superior Nut Company, Murray's, Dairy Queen packaged in 6.5 lb., 45 lb. Liquid Peanut Butter: Lot numbers 6.5 lb: 01020212; 01020312; 02020312; 01013112; 02013112; 03013112; 04013112; 05013112; 06013112; 07013112; 08013112; 03010312; 04020312; 05020312; 06020312; 07020312; 08020312; 01020112. Liquid Peanut Butter: 45 lb pail Lot Number: 09020312 Class II Aflatoxin test results above the established limit of 20 parts per billion Superior Nut Co. Inc.
Food Bliss Bros. Dairy Chocolate Peanut Butter Cookie Dough Ice Cream, 3-gallon round paperboard,: frozen Julian date code 2059 Class III Product contained recalled liquid peanut butter due to elevated aflatoxin levels Bliss Bros Dairy, Inc.
Food Newport Creamery Chocolate Peanut Butter Frozen Yogurt 3-gallon containers and 80 half gallon containers Julian date codes: 2053 and 2076 Class III Product contained recalled liquid peanut butter due to elevated aflatoxin levels Bliss Bros Dairy, Inc.
Devices Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process. Strip Part Number 7701513001 510 K- K063124 Device Listing Number - D001098 Integra MOZAIKTM Strip IOcc Reference number - CCM I021OITL Batch Number - 105BR0215955 Integra MOZAIKTM Strip 10cc Reference Number - CCM I021OITL Batch Number - 105BR0216149 Class II The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French, Integra LifeSciences Corp.
Devices Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process. Putty Part Number 7700713001 510 K- K062353 Device Listing Number - E604163 Integra MOZAIKTM Putty 2.5cc Reference No. - PTY10125ITL Batch number - 105BR02l5949 Integra MOZAIKTM Putty 5cc Refernce No. - PTY10155ITL Batch No. - 105BR0216024 Integra MOZAIKTM Putty lOcc Reference No.- PTY10210ITL Batch No. - 105BR0215956 Class II The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French, Integra LifeSciences Corp.
Biologics Plasma Frozen within 24 hours (FP24) 27LJ61487; 27LJ61493; 27KY04834; 27KY04854; 27LJ61492; 27LJ61496; 27LJ61505; 27LJ61729; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Greater Alleghenies Region
Biologics Red Blood Cells Leukocytes Reduced 27LJ61474; 27LJ61478; 27LJ61480; 27LJ61484; 27LJ61489; 27LJ61492; 27LJ61493; 27KY04851; 27LJ61487; 27LJ61496; 27LJ61501; 27LJ61505; 27GH55420; 27KY04822; 27KY04834; 27KY04854; 27LJ61707; 27LJ61729; 27LJ61732; 27LJ61733; 27LJ61737; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American Red Cross Greater Alleghenies Region
Drugs Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70. Lot #: 402794NV, Exp 12/13 Class III Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets. Endo Pharmaceuticals, Inc.
Drugs Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8. Lot #1856177, Exp 06/30/13 Class II Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. Ben Venue Laboratories Inc
Drugs Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1. Lot # 2006500, Exp 08/31/12 Class II Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. Ben Venue Laboratories Inc
Devices Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide n/a Class II When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplier used a different supplier for a specific integrated circuit "IC" (switched from Philips to Texas Instruments). On a specific control board, called PSM1 8 "CONTROL LOGIC BATTERY", the IC from Texas Instruments is showing an unwanted behavior and is issuing an incorrect Peak Signal of 2.2Vmax. This signal is enough to trigger the X-Ray exposure. Philips Healthcare Inc.
Food Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated EXPIRATION DATES : 5/31/12,6/7/12,6/14/12,6/21/12&6/28/12 Class II Product ingredient statement reversed for Reduced Fat Honey Walnut Cream Cheese and reduced Fat Hazelnut Cream Cheese Panera Bread LLC
Food Panera ,HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 0z , Refrigerated EXPIRATION DATES : 5/31/12,6/7/12,6/14/12,6/21/12&6/28/12 Class II Product ingredient statement reversed for Reduced Fat Honey Walnut Cream Cheese and Reduced Fat Hazelnut Cream Cheese. Product name is correct on label Panera Bread LLC
Devices T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots Class II The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids. Stryker Instruments Div. of Stryker Corporation
Devices T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots Class II The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids. Stryker Instruments Div. of Stryker Corporation
Devices Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures. Lot Number: 0312200152 Class II Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures. MicroAire Surgical Instruments, LLC
Devices The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311 Class II Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest score for severity and probability using the risk analysis process: - Calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds. Philips Medical Systems (Cleveland) Inc
Food Bourbon Seasoning 30458458, item number 30458458.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: brown sugar, maltodextrin, molasses, yeast extract, spices, dried tomato, worcestershire sauce (distilled vinegar, molasses, corn syrup, salt, caramel color, garlic powder, sugar, spices, tamarind, natural flavor, {contains Sulfiting Agents}), natural flavor, dried onion, gumacacia, malted barley flour, salt, sugar, corn syrup solids, citric acid, bourbon, and less than 2% of calcium stearate to prevent caking. Lot code 0423260110 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Spicy Chicken Marinade, item number 724435.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, modified corn starch, yeast extract, garlic powder, spice, onion powder, chicken fat, natural flavor, soybean oil, maltodextrin, citric acid, vinegar, and less than 2% silicon dioxide (to prevent caking). Lot codes 0412223806, 0412238007, 0417223803, 0417233804, 0423223805, 0423223806, 0504223801 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Prime Rib Rub, item number B18527.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, dextrose, yeast extract, malted barley extract, onion powder, garlic powder, spice, maltodextrin, spice extract, and less than 2% silicon dioxide (to prevent caking). Lot code 0423260202 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Spicy Chicken Marinade - Bake, item number 724444.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, yeast extract, modified corn starch, dried chicken broth, onion powder, garlic powder, natural flavor, dried red pepper sauce (aged red peppers, vinegar, salt, garlic) maltodextrin, soybean oil, citric acid, paprika extract (color), and less than 2% of calcium stearate to prevent caking. Lot code 0514223807 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Italian Marinade, item number 725450.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, dried garlic, sugar, corn syrup solids, maltodextrin, yeast extract, spices, dried onion, dried chicken stock, dried red bell pepper, paprika, lemon juice solids, chicken fat, garlic extract, citric acid, lemon oil, spice extracts, dried parsley, natural flavor, and less than 2% silicon dioxide and soybean oil (processing aids). Lot code 0508223803 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Thai Seasoning, item number 30502993.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: sugar, yeast extract, fructose, garlic powder, salt, maltodextrin, corn starch, modified corn starch, spices, dried red bell pepper, citric acid, vinegar, dextrose, dried red pepper sauce (aged red peppers, vinegar, salt, garlic) sodium deacetate, natural flavor, paprika extract (color), annatto extract (color), and less than 2% silicon dioxide to prevent caking. Lot code 0507260205 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Sliced Beef Gravy Seasoning, item number B17806.02 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 This product contains milk, soy, wheat (contains sulfiting agents) Ingredients: modified corn starch, hydrolyzed soy protein, autolyzed yeast extract, whey wheat flour, modified tapioca starch, onion powder, maltodextrin, guar gum, salt, caramel color, xanthan gum, natural flavor, disodium inosinate and disodium guanylate, spice. Lot code 0425223808 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Food Beef Patty Seasoning, item number B17187.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 contains soy Ingredients: hydrolyzed soy protein, salt, partially hydrogenated soybean and cottonseed oils, onion powder, dextrose, sugar, tomato powder, autolyzed yeast extract, disodium inosinate and disodium guanylate, vinegar, corn syrup solids, and less than 2% silicon dioxide (anti-caking agent). Lot code 0501224305 Class II Ingredients used to manufacture seasonings were found to be positive for Salmonella. Kerry Ingredients & Flavours Research & Developement Center
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186. Lot #: 43008, Exp 01/12; 48591, Exp 10/12 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. Lot #: 43783, Exp 01/12 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. Lot #: 41843, Exp 11/11 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W043212034914; Class II Blood Assurance Inc
Biologics Red Blood Cells W088412506324; Class II Blood products, collected from a donor taking the medication Finasteride, were distributed. Blood Bank Of Hawaii
Biologics Blood and Blood Products for Reprocessing W088411554476; W088412506324; Class III Blood products, collected from a donor taking the medication Finasteride, were distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells Leukocytes Reduced W311211002213; Class II Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Atlanta Blood Services
Biologics Fresh Frozen Plasma W311211002213; Class II Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Atlanta Blood Services
Food Private Selections Organic Baby Spinach, 5 oz plastic clamshell, UPC 0-11110-91128-5; Marketside Baby Spinach Organic, 10 oz plastic clamshell, UPC: 6-8113132900-2 Private Selections: Lot TFRS 130B 1503 KT34, Best By 5-25-2012; Lot TFRS 130B 1803 KT34, Best By 5-25-2012. Marketside: Lot TFRS130B16, Best by 5-25-2012. Class I USDA collected a sample and performed random sample on Marketside Organic Baby Spinach lot code TFRS 130B16 Best of Used By 5-25-12. This product tested positive for Salmonella. Taylor Farms Retail, Inc.
Food AlsoSalt Sodium Free Butter flavored Salt Substitute, 2.5 oz. bottle Exp:12/31/13, 12/31/12,12/30/11, Class II undeclared milk present in butter flavoring Diversified Natural Products, Inc.
Biologics Red Blood Cells Leukocytes Reduced W0685113628709; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Inland Northwest Blood Center
Biologics Recovered Plasma 12GE17891; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Red Blood Cells Leukocytes Reduced 12GE17891; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (the)
Biologics Platelets Pheresis Leukocytes Reduced W035412017900; Class II Community Blood Center
Food GB Select Roast Meat Type Flavor Net Wt. 55 lbs.(25 kg) Product of the Netherlands further processed in China and the US Batch #20389-EPP Plant #55-8822 Code 1742 Date produced 07 FEB 2012 Best Before 07 FEB 2014 Class II Flavor is contaminated with Salmonella Dsm Nutritional Products, Llc
Biologics Red Blood Cells W045611852841; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Community Blood Bank of Erie County
Biologics Blood and Blood Products for Reprocessing W045611852841; Class III Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Community Blood Bank of Erie County
Biologics Platelets Pheresis Leukocytes Reduced W140912127548; Class II Blood product, with pH below the acceptable level, was distributed. South Texas Blood & Tissue Center
Devices Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens Product Code VIH-4423 -- lots 92-057-9D, 95-041-9D, 97-063-9D, and 92-155-9D. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Product Code VIH-2233 -- lots 87-133-9D, 93-088-9D, 97-066-9D, 00-015-9D, 03-012-9D, 03-113-9D, 03-116-9D, 08-067-9D, 08-071-9D, 95-027-9D, 95-029-9D, and 08-073-9D. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Product Code VIH-2235 -- lots 86-088-9D, 87-106-9D, 89-080-9D, 90-048-9D, 91-058-9D, 91-059-9D, 91-135-9D, 92-110-9D, 93-062-9D, 93-063-9D, 94-034-9D, 94-044-9D, 95-030-9D, 95-052-9D, 97-051-9D, 97-053-9D, 97-071-9D, and 97-083-9D. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Product Code VIH-3333 -- lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, 97-040-9D, and 10-010-9D. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Product Code VIH-3335 -- lots 89-099-9D, 89-143-9D, 90-093-9D, 92-073-9D, 92-097-9D, 92-124-9D, 92-140-9D, 92-142-9D, 94-009-9D, 94-013-9D, 94-045-9D, 94-140-9D, 94-147-9D, 95-013-9D, 95-014-9D, 95-109-9D, 96-049-9D, 98-010-9D, 99-041-9D, 00-012-9D, 01-036-9D, 01-055-9D, 02-065-9D, 02-067-9D, 02-100-9D, 07-020-9D, 07-031-9D, 07-033-9D, 07-041-9D, 08-037-9D, 08-048-9D, 09-007-9D, 09-009-9D, 09-022-9D, 10-001-9D, 10-012-9D, 10-049-9D, 10-039-9D, 12-022-9D, and 12-026-9D. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-9848CP-11 -- lots 10J80 and 10K62. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-9889CP-7 -- lot 10I86. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-8522CP-3 - lot 10K50. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-7091CP - lot 11C119. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Devices Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Product Code AMS-8172CP-5 -- lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54. Class II Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Vygon Corporation
Drugs Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA. Lot #: YA02Z087A, YA02Z087B, YA02Z087C, YA02Z087D, YA02Z087E, YA02Z087F, Exp 03/27/17; YA022088A, YA022088B, YA022088C, YA022088D, YA022088E, YA022088F, YA022088G, YK01Z088A, YK01Z088B, YK01Z088C, YK01Z088D, YK01Z088E, YK01Z088F, YK01Z088G, Exp 03/28/17; YA02Z089A, YA02Z089B, YK01Z089A, YK01Z089B, Exp 03/29/17 Class II Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide. Airgas Inc
Biologics Blood and Blood Products for Reprocessing 003GL98734; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. The American National Red Cross - Southern Region
Biologics Platelets Pooled Leukocytes Reduced Irradiated W037712501098; Class II Blood product, collected from a donor who reported post donation illness, was distributed. Hoxworth Blood Center UC Medical Center
Devices PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015 Class II Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. Plasma Surgical Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115112158083F; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112158081J; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Drugs Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15 Lot#: 467061, Exp 09/11; 487551, Exp 11/11; 507521, Exp 1/12; 548051, Exp 5/12; 132171, Exp 8/12; 136571, Exp 11/12; 140181, Exp 1/13. Class II Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point. Bausch & Lomb, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043812520278; W043812520278; W043812520299; W043812520299; W043812201681; W043812201681; Class II Blood product, collected from a donor with unacceptably low hemoglobin, was distributed. LifeShare Community Blood Services
Food Florentine Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. West Best Foods, inc. 3425 Wynn Road, Las Vegas, NV 89102 Boxes have manufacturing dated on 04-23-2012 through 5/21/2012. Class II Soy was not included in the ingredient statement or allergen information on the label of Cheese Lasagna Rolls or Florentine Lasagna Rolls. Best West Foods
Food Cheese Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. West Best Foods, inc. 3425 Wynn Road, Las Vegas, NV 89102 Boxes have manufacturing dated on 04-23-2012 through 5/21/2012. Class II Soy was not included in the ingredient statement or allergen information on the label of Cheese Lasagna Rolls or Florentine Lasagna Rolls. Best West Foods
Biologics Platelets Pheresis Leukocytes Reduced W287312000866; W287312000866; W287312000866; Class II Quality Control and Distribution/Distribution of product that did not meet specifications LifeSource
Food Daufuski Brand boiled Oysters, 8 oz; Distributed by Liberty Gold Fruit, Inc. UPC 72810-00012 Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Liberty Gold Fruit Company, Inc.
Food Stahl's Famous Original Bakery CUTOUT COOKIES 14oz. INGREDIENTS: Pastry Flour, Sugar, Shortening...Contains Wheat, Eggs, Milk and Soy. Fresh by date: 6-1. UPC: 740174035155 Production date 4-25-12 Class II The finished product labels do not declare sub-ingredients of Wheat (flour), Yellow #6, Red 40, Red 3, Blue 2 and Blue 1. JDS Bakery LLC
Food White brick oven WHITE BREAD INGREDIENTS: Spring Flour (unbleached), water vegetable shortning... Stahl's Bakery (586) 716-8500 Fresh thru TUE 5-1 Class II The finished product labels do not declare sub-ingredients of Wheat (flour). JDS Bakery LLC
Food Cinnamon Rolls A Pastry Ingredients: Spring Flour (unbleached), water, powdered sugar sugar, vegetable shortening Net Wt 8oz Stahl's Bakery (586) 716-8500 Fresh thru WED 5-2 Class II The finished product labels do not declare sub-ingredients of Wheat (flour). JDS Bakery LLC
Food Bear Paws MICROWAVEABLE A Pastry Ingredients: Flour (unbleached), powdered sugar, sugar, walnuts, water, vegetable shortening Net Wt 8oz Stahl's Bakery (586) 716-8500 Fresh thru WED 5-2 Class II The finished product labels do not declare sub-ingredients of Wheat (flour). JDS Bakery LLC
Food 1) Chicken of the Sea Whole Oysters, 12 units per case, 8oz., UPC 4800000267; 2) Ace of Diamonds Whole Oysters 24 units per case, UPC 7760015508 UPC codes only Class III Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Food 1) Chicken of the Sea Whole Oysters Pieces 24 units per case, UPC 4800000069; 2) Pacific Pearl Whole Oysters Pieces 12 units per case, UPC 7175902112 UPC codes only Class III Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Food Pacific Pearl Smoked Oyster Water 12 units per case UPC 7175902119 Class III Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Food Polar Whole Boiled Oysters, 8 oz. net weight, 12 cans/carton. Case UPC#: 100-74027-02177-2 Product UPC#: 0-74027-00177-7 Class III MW Polar is recalling Polar Whole Boiled Oysters from Korea because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Milky Way Intl Trading Corp
Food Napoleon canned, Smoked Oysters, Medium. Item no. 48-312. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00312 7. The product is labeled in parts: "***NAPOLEON***Medium***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***". BEST BEFORE: MAY 2015; Can Code: OYSO M LY-39 1505; Can Code interpretation: OYSO = Smoked Oyters; M = Medium size; LY-39 = Packer Code; 1 = Year; 5 = Month; 04 = Date; Class III Korean canned Medium Smoked Oysters, Napoleon brand, are recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Napoleon Company, The
Food Napoleon canned, Smoked Oysters, Large. Item no. 48-313. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00313 4. The product is labeled in parts: "***NAPOLEON***Large***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***". BEST BEFORE: MAY 2015; Can Code: OYSO L LY-39 1506 Can Code interpretation: OYSO = Smoked Oyters; L = Large size; LY-39 = Packer Code; 1 = Year; 5 = Month; 06 = Date; Class III Korean canned Large Smoked Oysters, Napoleon brand, are recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Napoleon Company, The
Food Bumble Bee Fancy Whole Oysters 12/8 oz can. Case UPC 86600-75230 and unit UPC 86600-70030. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Bumble Bee International
Food Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12. UPC 073230000522, Case Code 00073230010521, CPI Item # 052. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Crown Prince Inc
Food Canned oysters. Crown Prince Natural Whole Boiled Oysters, 8 oz. Each case is 8oz/12. UPC 073230008528, Case Code 00073230018527, CPI Item # 852. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Crown Prince Inc
Food Canned oysters. Crown Prince Natural Smoked Oysters in Olive Oil, 3 oz. Each case is 3oz/18. UPC 073230008511, Case Code 00073230228513, CPI Item # 865. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Crown Prince Inc
Food Canned oysters. Crown Prince Natural Smoked Oysters with Chili Pepper, 3 oz. Each case is 3oz/18. UPC 073230008665, Case Code 00073230228667, CPI Item # 866. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Crown Prince Inc
Drugs Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA. Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01. Class II Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles. Hospira, Inc.
Food 1) Mrs.Friday's brand, Gourmet Breaded Oysters, Medium 18-25 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). 2) Mrs.Friday's brand, (Canada) Gourmet Breaded Oysters, Medium, Ready to Fry, Net Wt 2.5 lbs (1.13 kg), Distributed by King & Prince Corp., Brunswick, GA 31521. Product is packed in unlabeled, clear plastic bags. 1) Item #053820, Lot #0154K, 0168K, 0176K, 0217K, 0243K, 0257K, 0298K, 0308K, 0348K, 1007K, 1053K, 1077K, 1116K, 1124K, 1138K, 1166K, 1201K, 1222K, 1255K, 1277K, 1325K, 2005K, 2045K, 2070K, 2086K and 2103K. 2) Item #053821, Lot# 0176K, 0257K, 0298K, 0308K, 1053K, 1116K, 11328K, 1201K, 1255K, 1277K, 2005K and 2070K. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. King & Prince Seafood
Food Mrs.Friday's brand, Gourmet Breaded Oysters, Small 26-34 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). Item #053822, Lot #0154K, 0168K, 0176K, 0217K, 0243K, 0257K, 0298K, 0308K, 0348K, 1007K, 1077K, 1116K, 1138K, 1166K, 1222K, 1277K, 2005K, 2045K, 2070K, and 2103K. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. King & Prince Seafood
Food Mrs.Friday's Chef Dusted Pacific Oysters, 6/1 lb, Net Wt 6 lb (2.72 kg), Distributed By: King & Prince Seafood Corp., Brunswick, GA 31521. Product is packed in clear plastic bags with no individual labeling. Item #053826, Lot #0224K. Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. King & Prince Seafood
Drugs Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01. Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13 Class II Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam. Meridian Medical Technologies a Pfizer Company
Food Orchids brand Whole Oysters, Net Wt. 8 oz (226 g) Ingredients: oysters, salt, water. Packed for CTC Food Int'l Inc. South San Francisco, CA 94080 Product of Korea UPC 0 74601 0085 1; all codes Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. CTC Food International Inc
Food Orchids brand Smoked Oysters in cottonseed oil, salt added. Net Wt. 3 oz Ingredients: oysters, salt, water. Packed for CTC Food Int'l Inc. South San Francisco, CA 94080 Product of Korea UPC 0 74601 00090 5; all codes Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. CTC Food International Inc
Food Campbell's Oyster Stew, Net Wt 10.5 oz (298g), Campbell Soup Company, Camden, NJ 08103-1701 UPC Code: 5100003087-0 Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Campbell Soup Supply Co., LLC
Food Fresh Baby Clam Meat Labels on outer styrofoam container; 200 g packages, 30 or 40 packages/case, refrigerated. Refrigerate after opening. Product arrived via Korean Air Cargo directly to consignees. No code information available at this time Class II The shellfish was harvested from waters that may have been exposed to inadequate sanitation controls. Jinhee Seo
Drugs Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146. Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13 Class II Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. Physicians Total Care, Inc.
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