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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Class I Food Event

Event ID64315
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDZH Import & Export Inc.
CityBrooklyn
StateNY
CountryUS
Distribution PatternNew York City
 

Associated Products

Product DescriptionDried mushrooms sold under the following brand names: 1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 1/2 cup (7g dry) (30g reconstituted) -- Servings Per Container about 4. --- The product is packed on a plastic tray inside a plastic bag. 2) MOUNTAINS brand DRIED MUSHROOM, NET WT: 35G (1.23 OZ) , UPC 6 931653 104064, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --- Nutrition Facts: Serving Size 100g -- Servings Per Container 3 --- The product is packed on a plastic tray inside a plastic bag.
Code Info1) BEST BEFORE: MAY 3rd, 2013. 2) Best Before: Nov.30, 2013.
ClassificationClass I
Reason for Recall1) The product contained undeclared sulfites (7984 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. 2) The product contained undeclared sulfites (7943 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Product Quantity1) 15 cases (50 x 35 gram packages per case) 2) unknown
Recall NumberF-1371-2013

Class I Food Event

Event ID64385
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBuffalo Trace Distillery
CityFrankfort
StateKY
CountryUS
Distribution PatternProduct was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom.
 

Associated Products

Product DescriptionBUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00105 8 Best By 2/16/14
Code InfoBest By 2/16/14
ClassificationClass I
Reason for RecallThe firm failed to include allergen milk on the label of this sauce.
Product Quantity1,504/8 fl. oz. jars
Recall NumberF-1372-2013
Product DescriptionBUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00103 4 Best By 1/30/14
Code InfoBest By 1/30/14
ClassificationClass I
Reason for RecallThe firm failed to include allergens of milk and soy on the label of this sauce.
Product Quantity1,686/8 fl. oz. jars
Recall NumberF-1373-2013
Product DescriptionBUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00107 2 Best By 10/30/14
Code InfoBeset By 10/30/14
ClassificationClass I
Reason for RecallThe firm failed to include allergens of wheat and anchovy on the label of this marinade. Soy sauce is listed, but soy is not listed as the source of the sauce.
Product Quantity993/12 fl. oz. bottles
Recall NumberF-1374-2013
Product DescriptionBUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00106 5 Best By 1/19/15
Code InfoBest By 1/19/15
ClassificationClass I
Reason for RecallThe firm failed to include allergens of soy and anchovy on the label of this sauce.
Product Quantity1,658/16 fl. oz. jar
Recall NumberF-1375-2013
Product DescriptionBUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00017 4 Best By 11/7/14
Code InfoBest By 11/7/14
ClassificationClass I
Reason for RecallThe firm failed to include allergens of soy and anchovy on the labels of this sauce.
Product Quantity635/16 fl. oz. jars
Recall NumberF-1376-2013

Class I Devices Event

Event ID64439
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Neuromodulation
CityMinneapolis
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.
 

Associated Products

Product DescriptionMedtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy.
Code Infoall product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.
ClassificationClass I
Reason for RecallThere is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.
Product Quantity30,000
Recall NumberZ-1190-2013
Product DescriptionMedtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
Code Infoall product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.
ClassificationClass I
Reason for RecallThere is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.
Product Quantity30,000
Recall NumberZ-1191-2013

Class I Food Event

Event ID64595
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNutrex Research, Inc.
CityOviedo
StateFL
CountryUS
Distribution PatternCT, FL, GA, IL, MA, NJ, NV, and TX
 

Associated Products

Product DescriptionNutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer
Code InfoLot # 50000114 Best by: 01/2015
ClassificationClass I
Reason for RecallProduct samples contain DMAA (Methylhexanamine).
Product Quantity82,417 sample packets (1 capsule each)
Recall NumberF-1300-2013

Class I Devices Event

Event ID64645
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.
 

Associated Products

Product DescriptionMaquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
Code InfoSERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.
ClassificationClass I
Reason for RecallWhen using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
Product Quantity90,000 units (batteries)
Recall NumberZ-1177-2013

Class I Food Event

Event ID64788
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmRich Products Corp
CityBuffalo
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 41322 37813 2; Product Code 37691 Net Wt. 7-oz cartons-UPC Code 0 41322 37691 6; Product Code 32521 and 32522; Net Wt. 44-oz cartons-UPC 0 41322 32521 1; Product Code 37455 Net Wt. 2 lb. cartons-UPC Code 0 41322 37455 4, Market Day, Net Wt.. 22-oz cartons-UPC Code 0 41322 80435 8, Product Code 80435; Schwan's Baked Mozzarella Bites Net Wt.. 22 oz bags- UPC Code 0 72180 61008 9, Product Code 61008, the production date range for these products is 3G1182XXXX - 3G3088XXXX.
Code InfoJulian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013
ClassificationClass I
Reason for RecallProducts potentially contaminated with E. coli O121.
Product Quantity820,577 cases
Recall NumberF-1367-2013
Product DescriptionFarm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268.
Code InfoJulian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013
ClassificationClass I
Reason for RecallProducts potentially contaminated with E. coli O121.
Product Quantity21,874 cases (product code 65265), 185,646 cases ( product code 65268)
Recall NumberF-1368-2013
Product DescriptionFarm Rich Better For You Pizza Dippers-Pizza Dough made with Whole Wheat Flour and Stuffed with Mozzarella Cheese and Reduced Fat Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 00041322652782, Product Code 65278.
Code InfoJulian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013
ClassificationClass I
Reason for RecallProducts potentially contaminated with E. coli O121.
Product Quantity15,273 cases
Recall NumberF-1369-2013
Product DescriptionFarm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233.
Code InfoJulian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013
ClassificationClass I
Reason for RecallProducts potentially contaminated with E. coli O121.
Product Quantity12,687 cases
Recall NumberF-1370-2013

Class I Devices Event

Event ID64837
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
 

Associated Products

Product DescriptionThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.
Code InfoList Numbers: 13000, 13100, 13150
ClassificationClass I
Reason for RecallPump shutting off during use without warning.
Product QuantityList Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps
Recall NumberZ-1169-2013
Product DescriptionThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.
Code InfoList Numbers: 13086, 13087, 13088
ClassificationClass I
Reason for RecallPump shutting off during use without warning.
Product QuantityList Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,942 pumps
Recall NumberZ-1170-2013

Class I Devices Event

Event ID64839
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
 

Associated Products

Product DescriptionGemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Code InfoList Numbers: 13000, 13100, 13150
ClassificationClass I
Reason for RecallBattery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Product QuantityList Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps
Recall NumberZ-1159-2013
Product DescriptionGemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Code InfoList Numbers: 13086, 13087, 13088
ClassificationClass I
Reason for RecallBattery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Product QuantityList Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
Recall NumberZ-1160-2013

Class I Devices Event

Event ID64851
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNewport Medical Instruments Inc
CityCosta Mesa
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
 

Associated Products

Product DescriptionNewport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.
Code InfoModel number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F
ClassificationClass I
Reason for RecallNewport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
Product Quantity2528 ventilators and 1864 power pac batteries
Recall NumberZ-1171-2013

Class I Food Event

Event ID64896
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWegmans Food Markets
CityRochester
StateNY
CountryUS
Distribution PatternNY, NJ, PA, VA, MD & MA
 

Associated Products

Product DescriptionWegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286
Code Infoexpiration date 5/17/13, Lot# 13081
ClassificationClass I
Reason for RecallWegmans Foods Markets issued a Press Release on April 16, 2013 and is recalling affected units of Roasted Red Pepper Dip because some of the tubs may have an incorrect ingredient label that does not list milk and eggs.
Product Quantity1,110 units (81 cases)
Recall NumberF-1366-2013

Class II Biologics Event

Event ID44611
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLX62656
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was considered at risk for human immunodeficiency virus (HIV) Group O, was distributed.
Product Quantity1 Unit
Recall NumberB-0767-13

Class II Biologics Event

Event ID46461
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced Irradiated
Code Info2411524B
ClassificationClass II
Reason for RecallBlood product, with an unacceptable platelet yield, was distributed.
Product Quantity1
Recall NumberB-1230-13

Class II Biologics Event

Event ID47321
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternOregon, Florida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW137507102679; 7242381; 7239762.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Product Quantity3 components
Recall NumberB-1099-13

Class II Biologics Event

Event ID48584
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CitySalt Lake City
StateUT
CountryUS
Distribution PatternMontana.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20GH52851
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 component
Recall NumberB-1027-13

Class II Biologics Event

Event ID49628
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Feb-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina.
 

Associated Products

Product DescriptionSource Plasma
Code Info367094508, 367093944, 367095063
ClassificationClass II
Reason for RecallBlood products, which were not tested for viral markers, were distributed.
Product Quantity3 Components
Recall NumberB-1105-13

Class II Biologics Event

Event ID50956
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Nov-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info366079288; 366079360; 366082135; 366083179; 366084190; 366084634; 366085317; 366087202; 366087644; 366088694; 366089200; 366090702; 366091164; 366092335; 366093126; 366094294; 366095581; 366096218; 366085779, 366097224, 366097722, 366099231, 366099613, 366100689, 366101179, 366105600, 366107419, 366108864, 366109940, 366110474, 366111772, 366114206, 366121907, 366122282
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.
Product Quantity34 units
Recall NumberB-1106-13

Class II Biologics Event

Event ID54065
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternIL, CA
 

Associated Products

Product DescriptionSource Plasma
Code Info4240016562 4240016227 4240015380 4240019033 4240017662 4240017149 4240016718 4240016220 4240015901 4240030578 4240030110 4240016888 4240016386 4240015849 4240031050 4240030277 4240029767 4240029010 4240027582 4240026960 4240026400 4240025974 4240025449 4240023612 4240021904 4240020798 4240019172 4240018309 4240017985 4240031664 4240030930 4240030040 4240029138 4240028890 4240027868 4240027424 4240026619 4240025983 4240025072 4240024643 4240024006 4240023727 4240022978 4240022487 4240022051 4240021532 4240021026 4240020416 4240019859 4240018893 4240018118 4240017413 4240017098 4240031569 4240031145 4240022279 4240021514 4240020986 4240020217 4240019301 4240018474 4240024389 4240023957 4240023324 4240022314 4240021943 4240020942 4240020343 4240017705 4240017037 4240016854 4240016974 4240016003 4240031444 4240030845 4240030296 4240029609 4240029159 4240028483 4240028008 4240027314 4240026695 4240025384 4240024794 4240024300 4240023723 4240023240 4240022725 4240022260 4240021740 4240021248 4240020715 4240019773 4240019229 4240018847 4240017527 4240017196 4240015773 4240015201 4240028382 4240027207 4240026812 4240025011 4240024238 4240023782 4240023276 4240022528 4240022215 4240021646 4240019351 4240017364 4240016660 4240015994 4240018750 4240018439 4240020270 4240019348 4240018999 4240018453 4240018146 4240017498 4240017506 4240016406 4240015740 4240024979 4240024268 4240023664 4240022810 4240022245 4240021855 4240021278 4240020674 4240020299 4240015135 4240018949 4240018538 4240017921 4240017763 4240017128 4240022320 4240021553 4240020538 4240019964 4240018725 4240018177 4240017849 4240017396 4240017141 4240032046 4240031443 4240030744 4240030299 4240029608 4240029165 4240028482 4240028007 4240027315 4240026696 4240025246 4240024818 4240023728 4240023109 4240022717 4240022119 4240021732 4240021124 4240020712 4240020135 4240019780 4240019231 4240018853 4240016676 4240016320 4240015756 4240015180 4240024525 4240024131 4240015900 4240015435 4240021571 4240020876 4240018517 4240018133 4240017664 4240032147 4240031623 4240030990 4240028535 4240028036 4240027422 4240026779 4240018232 4240016692 4240016184 4240015669 4240029499 4240028885 4240027184 4240026221 4240025289 4240024617 4240023463 4240023051 4240021944 4240020989 4240019505 4240019120 4240018459 4240017894 4240017397 4240031420 4240030961 4240030412 4240029965 4240029264 4240028784 4240028126 4240027734 4240027023 4240026562 4240026001 4240025645 4240024909 4240024463 4240023827 4240023402 4240022807 4240022116 4240021726 4240021024 4240020611 4240020035 4240019628 4240019086 4240018569 4240018313 4240018751 4240018216 4240017060 4240015349 4240018564 4240018161 4240017299 4240016479 4240015601 4240018866 4240018431 4240016325 4240015925 4240017940 4240017485 4240017159 4240032144 4240031609 4240030976 4240030596 4240029886 4240029418 4240028729 4240028294 4240027597 4240027141 4240026567 4240026201 4240025327 4240024959 4240024221 4240023802 4240023004 4240022542 4240021379 4240020877 4240019328 4240017887 4240017773 4240017186 4240025047 4240017081 4240016217 4240015971 4240015322 4240015167 4240019531 4240019212 4240018583 4240018329 4240017806 4240017348 4240016952 4240016264 4240017816
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity291
Recall NumberB-1023-13

Class II Biologics Event

Event ID54938
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC, CA
 

Associated Products

Product DescriptionSource Plasma
Code Info4240013647;4240013121;4240012766;4240012300; 4240012033;4240011179;4240010766;4240010449; 4240006845;4240026822;4240018069;4240017563; 4240017259;4240016368;4240015639;4240015315; 4240014793;4240014514;4240010109 ,4240009093 , 4240008806 ,4240008423 ,4240008143 ,4240007781 , 4240007410 ,4240007180 ,4240006880 ,4240022328 , 4240021971 ,4240011906 ,4240010160 ,4240009557 , 4240008949 ,4240008764 ,4240007707 ,4240006878
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity36
Recall NumberB-1022-13

Class II Biologics Event

Event ID59790
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3720428066; 3720425381; 3720421643; 3720420290; 3720418232; 3720416926; 3720415044; 3720413553; 3720411637; 3720410338; 3720407547; 3720405571; 3720404375; 3720402283; 3720400924; 3720398718; 3720397548; 3720394685; 3720392539; 3720390508; 3720388882; 3720386356; 3720384555; 3720382661; 3720380724; 3720379181; 3720377420; 3720375711; 3720370641; 3720368970; 3720364462; 3720362699; 3720360261
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical exam was incomplete, were distributed.
Product Quantity33 units
Recall NumberB-1154-13

Class II Biologics Event

Event ID64074
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells
Code Info8405574;
ClassificationClass II
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0987-13

Class II Biologics Event

Event ID64120
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW1170125196435;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Product Quantity1
Recall NumberB-0988-13

Class II Biologics Event

Event ID64122
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBeth Israel Medical Center, The Ralph Gore Blood Bank
CityNew York
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Irradiated
Code InfoW139312000229;
ClassificationClass II
Reason for RecallBlood product, labeled as leukoreduced, but which had not undergone leukoreduction, was distributed.
Product Quantity1
Recall NumberB-0990-13

Class II Biologics Event

Event ID64123
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112245276;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1
Recall NumberB-0991-13

Class II Biologics Event

Event ID64124
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112265889;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0992-13

Class II Biologics Event

Event ID64125
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112261399;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1
Recall NumberB-0993-13

Class II Biologics Event

Event ID64167
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036812464017;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1070-13

Class II Biologics Event

Event ID64171
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee; Indiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043212079287;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1080-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW043212079287;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1081-13

Class II Biologics Event

Event ID64174
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW037711505342;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1082-13
Product DescriptionFresh Frozen Plasma
Code InfoW037712012893; W037711179346;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-1083-13

Class II Biologics Event

Event ID64183
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWisconsin
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036310008862 Part 1; W036310008862 Part 2;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-1084-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036309001612; W036309014482;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-1085-13

Class II Biologics Event

Event ID64191
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest Tennessee Regional Blood Center Inc
CityJackson
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW040812117259;
ClassificationClass II
Reason for RecallBlood product, which wase collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1086-13

Class II Biologics Event

Event ID64192
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Dec-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmCentral Pennsylvania Blood Bank
CityHummelstown
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW270112571961;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1087-13

Class II Biologics Event

Event ID64207
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedic Inc
CityKnoxville
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW071209008364 Part 1; W071209008364 Part 2;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2
Recall NumberB-1108-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW071208025659; 9312114; 9468600; 9263803;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity4
Recall NumberB-1109-13
Product DescriptionFresh Frozen Plasma
Code Info9468600; 9505841;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2
Recall NumberB-1110-13
Product DescriptionRed Blood Cells Irradiated
Code Info9440117;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1
Recall NumberB-1111-13
Product DescriptionPlatelets
Code Info9440117; 9427804; 9226669;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity3
Recall NumberB-1112-13
Product DescriptionRed Blood Cells
Code Info9505841; 9088034; 9427804; 9226669; 9359488;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity5
Recall NumberB-1113-13

Class II Devices Event

Event ID64504
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmB. Braun Medical, Inc.
CityAllentown
StatePA
CountryUS
Distribution PatternNationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
 

Associated Products

Product DescriptionDiacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Code InfoLot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012.
ClassificationClass II
Reason for RecallThere is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
Product Quantity1580
Recall NumberZ-1183-2013

Class II Devices Event

Event ID64589
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarestream Health, Inc.
CityRochester
StateNY
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionCareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Code InfoCS 2100
ClassificationClass II
Reason for RecallThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Product Quantity167 installed in the US
Recall NumberZ-0999-2013
Product DescriptionCareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Code InfoCS 2200
ClassificationClass II
Reason for RecallThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Product Quantity167 installed in the US
Recall NumberZ-1000-2013
Product DescriptionCareStream Dental Kodak 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Code InfoCS 2100
ClassificationClass II
Reason for RecallThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Product Quantity167 installed in the US
Recall NumberZ-1094-2013
Product DescriptionCareStream Dental Kodak 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Code InfoCS 2200
ClassificationClass II
Reason for RecallThere have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
Product Quantity167 installed in the US
Recall NumberZ-1095-2013

Class II Devices Event

Event ID64621
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jul-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDiscus Dental LLC
CityCulver City
StateCA
CountryUS
Distribution PatternNationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA.
 

Associated Products

Product DescriptionSL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
Code InfoModel LR2002
ClassificationClass II
Reason for RecallThe firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
Product Quantity150 units
Recall NumberZ-1186-2013

Class II Drugs Event

Event ID64634
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-13
Initial Firm Notification of Consignee or Public
Recalling FirmCarib Import & Export, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNationwide, Bahamas, and Turks & Caicos Islands
 

Associated Products

Product DescriptionInfants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.
Code InfoLot JZ28, Exp 03/13
ClassificationClass II
Reason for RecallCGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Product Quantity480 bottles
Recall NumberD-307-2013

Class II Drugs Event

Event ID64710
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNoven Pharmaceuticals, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionDaytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Code InfoLot #59824, Exp 04/13
ClassificationClass II
Reason for RecallDefective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Product Quantity335,910 patches
Recall NumberD-312-2013

Class II Drugs Event

Event ID64720
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionPreservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Code InfoLot 15-065-DK, Exp 1SEP2013
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Product Quantity26,100 vials
Recall NumberD-308-2013
Product DescriptionDiazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Code InfoLot 17-100-EV and 17-399-EV
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product Quantity172,350 vials
Recall NumberD-309-2013

Class II Drugs Event

Event ID64753
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDonnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
Code InfoLot # 68864; exp 04/13
ClassificationClass II
Reason for RecallLabeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Product Quantity1,258 bottles
Recall NumberD-306-2013

Class II Devices Event

Event ID64812
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMasimo Corporation
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
 

Associated Products

Product DescriptionRad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Code InfoCatalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
ClassificationClass II
Reason for RecallMasimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Product Quantity42,908 units
Recall NumberZ-1187-2013

Class II Devices Event

Event ID64820
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmNxStage Medical, Inc.
CityLawrence
StateMA
CountryUS
Distribution PatternNationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
 

Associated Products

Product DescriptionNxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Code InfoF023444
ClassificationClass II
Reason for RecallProduct may be mislabeled.
Product Quantity1480 cases (2 bags per case)
Recall NumberZ-1214-2013

Class II Devices Event

Event ID64833
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVital Images, Inc.
CityMinnetonka
StateMN
CountryUS
Distribution PatternWorldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.
 

Associated Products

Product DescriptionVitrea® CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Code InfoVersions 6.0 and above. Serial Numbers: VPE0503066 VPE0911551 VPE0908462 324112 VPE0503082 VPE0707078 VPE0707079 5040227558 5040227590 VPE0503081 VPE0609168 5040227140 VPE0707067 VPE1006732 VPE1011765 VPE0707087 5080113685 VPE0802171 VPE0805209 VPE0805281 VPE0902329 475604 5080121211 357678 5080119381 395647 5090112096 449462 VPE1003630 5090102007 VPE0502007 VPE0602118 VPE0602122 VPE0602117 N/A N/A VPE0503073 475635 5090111480 5090111472 5040227329 5031211482 5040919344 VPE0602131 5080117869 5090111960 373409 5090103704 VESADLCC1206033 5090102775 N/A VPE0503080 5080121653 VPE1211025 5080117230 5030861645 5090104980 470268 5090102848 5080116463 VPE0503068 VPE0707080 VPE0707074 5040227507 5080116269 VPE0503048 5090114366 VPE0710133 5080116382 5080115025 5090110263 VPE0503079 VPE1006755 VPE0503052 5040919425 5090103755 VPE0502024 5040919263 5080119233 VPE0503046 VPE0503059 UPGD1011004 VPE0502001 5080113057 N/A VPE1202981 5090112835 VPE0702039 5090102252 VESADLCC1209037 5090109508 5090114188 5080108460 5080117117 VPE0503047 5080117486 VPE0710128 VPE0710129 VPE0502002 VPE0710130 VPE0502010 VPE0602145 5090104069 5080115149 5080119934 5080118016 VPE0906417 5090106126 5080111321 VPE0503058 VPE1003661 VPE0502003 VPE1006713 5040227345 VPE0805279 439533 VPE0702040 VPE0503102 VPE1011763 VPE0805246 N/A VPE0602113 5080120029 VESADLCC1211040 5040227310 5080105909 5090102074 VPE0602112 VPE0503064 5080121645 475539 N/A VPE0609176 5090112495 VPE0707053 5090108706 N/A 5030852743 361131 5090111510 306459 5080111550 5090109265 VPE0609205 5080120290 VPE0602152 VPE0805276 5031221628 VPE0906416 475819 545925 VPE0602124 5090110042 VPE0710141 VPE0710142 VPE0502014 5080117524 5080118652 VPE0503089 VPE0802199 5080113324 320549 VPE0503050 VPE0802177 5040227035 5030861602 5080114800 VPE0609208 5080113030 5080118075 486565 5080115343 5090102651 5080122803 ENP1106001 361117 VPE0503103 VPE0503051 5090106398 5090106428 5090109486 VPE0503076 VPE0805270 5030852816 N/A VPE0602140 VPE0707065 5080113790 5080113049 5080111232 VPE0609163 5090105723 VPE0602119 VPE1003624 5080111313 VPE0609170 5080116501 5040226950 VPE0502008 VPE0502029 VPE0602129 VPE0609190 VPE0602123 VPE0502028 VPE0602149 5090106703 VPE0609171 VPE0805288 475818 VPE0702037 5031211520 5080113103 5080117877 357732 5090108420 VPE0502005 518294 5090109346 VPE0503069 5080116277 VPE0602155 518306 VPE0602114 VPE0602135 VEP0609160 VPE0702015 VPE0503065 VPE0710149 5080109467 5090112983 5080121599 VPE0702038 VPE0702027 5030852972 VPE1003612 5080117109 VPE0805216 5090104107 VPE0602111 N/A 5090110190 5080120452 5030861696 5080116528 VPE0602141 5080119993 VPE0702047 5090113246 N/A VPE0902360 N/A 5080122943 N/A 5080115629 413584 VPE0502023 5090102031 VPE1108820 5080115270 5080119411 5040227086 VPE0707086 5080121688 5030853006 VPE1202992 5090110034 N/A VPE0805239 5090109397 VESADLCC1209038 5080118989 338704 5080119667 VPE0503104 VPE0805206 5021022946 VPE0602150 VPE0503033 VPE0802161 VPE0609184 VPE0503032 included 5080117087 VPE0503096 VPE0609158 VPE0702032 N/A 475605 475607 VPE0902359 VPE0802178 VPE0805287 VPE0502004 VPE0805285 5090111502 5080123230 VPE0805236 5090113440 5040227051 5040227167 5080116536 VPE0902368 VPE0908467 VPE0609159 VPE0609175 5090113254 5080117265 5031211431 5080122722 5090107300 411472 VPE0702033 5080113707 VPE0609181 5080112980 VPE1011757 5090106827 5090106843 5090111871 VPE0702008 5040919328 included VPE0702006 VPE0609157 5090109257 5040919360 5090110646 5090108528 5090112525 N/A VPE0609179 5090110026 5090107319 VPE0602121 VPE0802170 VPE0503098 5040227485 5040919522 VPE0805207 5040227523 5030861025 5080123206 VESADLCC1206034 5080120193 5080108479 VESADLCC1209036 VPE0602110 VPE0710134 5080119470 475817 318998 5080121793 5080119675 5030860940 5090113416 VPE0503084 535678 5090111383 5080120053 VPE0902345 VPE0906400 VPE1006730 5080120797 476239 5090113459 5090113475 VPE0805280 5080119810 5080106980 475614 VPE0503086 5090104735 5090106533 5080115408 VPE1003625 475642 5090104182 VPE0805215 VPE0602108 5080118679 VPE0707094 358375 VPE0502022 5080113243 358016 VPE0503099 358022 341884 VPE0609169 5080116625 5080109971 475665 VPE0707084 vpe0609166 N/A VPE0710105 5080121831 5080115793 VPE0902334 VPE0702050 5090110697 UPGD1009001 5090112363 VPE0911559 VPE0805290 VPE0805291 5080117931 VPE0710150 VPE0502020 5080112859 VPE0602133 VPE0503057 VPE0710110 VPE0802169 5090111359 VPE1202977 VPE0810275 5080117915 406861 5090104433 5080119616 5090109737 5080117990 5040227280 5090108471 5090109109 5090109745 VPE0810239 5040227124 VPE0902354 VPE0707095 5090108889 5090109117 352961 5080120878 VPE0908473 5021022881 5080121343 VPE0503063 VPE1003629 VPE0502021 VPE0502012 5090114242 464678 VPE0502013 VPE0502016 475641 475640 VPE0502009 VPE0502018 VPE1006719 5040919387 413350 475671 493854 5090114161 VPE0908491 5090113351 VPE0503038 VPE0503040 VPE1108819 5080114967 VPE0503042 VPE1202968 VPE0503062 VPE0503060 VPE0602128 5080115092 VESADLCC1204031 428789 VPE0503070 5090108641 440930 314674 VPE0503088 359634 VPE0609172 VPE0503078 475672 5090108552 VPE0503074 363684 363698 5030542779 VPE0503101 5080121041 VPE0503075 365166 365180 VPE0503094 VPE0503095 336194 VPE0503097 5080117095 5090106819 VPE0503087 355511 VPE0503092 VPE0503093 VPE0602107 5090106908 VPE0802182 VPE0602134 5080123400 VPE0503105 VPE0602116 VPE0908482 VPE0908481 VPE0908480 VPE0810247 VPE0810248 475820 VPE0908487 5090105936 475639 475638 VPE0602148 VPE0602143 VPE0602137 VPE0602132 VPE0602126 VPE0602130 VPE0602146 VPE0503041 5090108331 VPE0609364 VPE0503067 5080112735 VPE0710106 5080122684 VPE0502011 VPE0609174 VPE0602109 N/A VPE1006752 VPE1006747 VPE0609177 5090102155 5090102171 VPE0602142 N/A N/A N/A VPE1109877 VPE0609183 TSV1111004BRNPERF2D VPE0602144 441203 5090113165 51VPE27668001 5090108005 VPE0609191 VPE0702029 VPE0503061 5090107459 VCF1112823 VPE0609198 526540 5080121157 VESADLCC1201030 VPE0902339 VPE0609173 5090111391 372642 VPE0911580 5080116587 VPE0902335 5090111804 552972 5080117567 VPE0710138 VPE0810256 5090111073 VPE0802167 VPE0609180 VPE0609195 VPE0609194 5090111022 VPE0702013 VPE0702014 5090103836 5090106290 439547 VPE0707077 VPE0602151 5090111375 VPE0609167 5080118954 VPE0609207 5080121777 475783 5080117192 5090106711 VPE0609203 VPE0609204 5080112344 VPE0609196 51VPE2791801 VPE0609211 VPE0609212 VPE0710145 5080109904 LTB1109027 N/A N/A UPGD1009002 VPE0702016 VPE0702007 5080109890 VPE0609206 5090106487 5090112851 VPE0609210 VPE0609182 UPGD1103007BRNPERF2D 5090106339 VPE0710103 VPE0902353 5080115262 5080121815 VPE1006718 VPE1202988 VPE0609186 5090113378 5090104379 5090106754 5090109087 VPE0908458 5090102309 VPE0911576 VPE0707064 VPE1003657 VPE0609188 VPE0609187 VPE0702004 VPE0805210 VPE0710118 VPE0702003 5090105715 5090108455 VPE0702011 VPE0702012 TSV1003001BRNPERF2D 5090109222 VPE0702009 VPE0702010 VPE0702002 VPE1111913 VPE0911582 553062 VPE0707056 VPE0802187 5090111235 VPE0702023 5080116064 N/A VPE0702025 VPE0707085 VPE0702026 VPE0702028 VPE1202964 VPE0702031 5080117893 5090110077 VPE0702041 5090112533 VPE0702043 VPE0707061 VPE0906420 5080119683 VPE0702021 5080120231 486555 346887 5090113084 VPE1003619 VPE1006722 VPE0702030 475673 VPE0602154 VPE0602127 517799 VPE0702034 VPE0702022 5080103922 N/A N/A VPE0702048 VPE0609202 VPE0707055 VPE0707054 VPE0702046 392926 5080116803 VPE0702049 5080118571 VPE0609209 VPE0707052 VPE0707062 VPE0805267 VPE0805266 VPE0707058 5080122420 VPE0707057 VPE0707072 VPE0908460 5090104727 VPE0707060 VPE1006751 VPE0707068 VPE1108868 VPE0707073 VPE0707069 VPE0707070 VPE0707071 VPE0707092 VPE0707076 VPE0707091 5080121971 VESADLCC1109026 VPE0702005 VPE1211041 5080106999 VPE0707066 VPE0707081 VPE0710112 VPE0710109 VPE0707063 487626 VPE0710108 VPE0710107 VPE0805218 VPE0710126 5080107014 5080114851 VPE0710136 VPE0707099 5080105593 VPE1011773 N/A N/A VPE0710137 VPE0802181 VPE0707051 5080120894 VPE0710121 VPE0710124 VPE0710101 VPE0707082 5090108730 VPE0710120 VPE0710122 5080115645 VPE0710116 VPE0707097 VPE0710123 VPE0710125 VPE0902370 VPE0707083 VPE0805255 VPE0710102 5090106746 VPE0710144 VPE0710140 5090111812 VPE0707100 5090109656 VPE0802153 VPE0710111 5090113157 VPE0802151 5080117923 VPE0802155 VPE0802160 VPE0707098 VPE1003659 VPE0710139 VPE0802168 VPE0802157 VPE0802158 VPE0710148 VPE0802185 VPE0802184 VPE0710147 VPE0802154 VPE0710143 5080121807 VPE0710146 VPE0710114 VPE0802166 VPE0802163 5090106738 VPE0802156 VPE1202991 VPE0802183 VPE0802152 VPE0802192 VPE0710115 VPE0710135 VPE0802189 VPE0802165 475784 475785 VPE0802188 VPE0902349 UPGD1106009 VPE0802191 5080111569 VPE0802194 VPE0802193 VPE0707093 VPE0805204 VPE0805205 VPE0805212 VPE0805202 VPE0805214 VPE0802200 VPE0710117 VPE1011756 5090108536 VPE0802172 475674 475821 VPE0805219 VPE0802196 VPE0802197 VPE0802198 VPE0707096 VPE0710119 VPE0802162 VPE0805217 475687 5090103429 VPE0805278 VPE0805224 VPE0802164 VPE0805211 VPE0802174 VPE0805213 VPE0805220 VPE0805232 5080110457 5080119268 475688 VPE0710113 5080103698 VPE0805284 VPE0805223 VPE0805203 475715 VPE0805227 VPE0805228 475689 VPE0802176 475694 475693 VPE0805233 475690 VPE0805259 475692 VPE0805225 51VPE2895602 51VPE2895601 VPE0810246 5080115912 5080115211 475716 VPE0805201 475772 VPE0805221 VPE0805241 VPE0805244 VPE0805251 VPE0805250 VPE0805252 VPE0805245 VPE0805226 VPE0805271 VPE0805269 VPE0805268 VPE0805274 360111 475634 5080115254 326419 5080106263 VPE0802195 VPE0805229 5080104775 VPE0805272 5080106255 VPE0805277 VPE0805253 VPE0805230 VPE0805297 VPE0805298 VPE0805295 VPE0805296 VPE0805286 VPE0810262 VPE0810261 VPE0805289 VPE0810238 VPE0805300 VPE1003671 VPE0805242 VPE0805299 VPE0810237 VPE0805282 475773 VPE0805222 VPE0805273 VPE1011772 5080107421 5080107332 363717 363731 VPE0810240 VPE0805262 VPE0805263 VPE0805264 VPE0810235 VPE0810233 VPE0805293 VPE0805292 VPE0805294 VPE0810234 VPE0810250 VPE0810232 VPE0810236 VPE0810255 VPE0609213 VPE0810244 VPE0805283 VPE0810245 475776 VPE0802190 5090113394 5080108436 475778 475774 VPE0810253 VPE0810259 VPE0810243 VPE0810242 VPE0805231 VPE0810264 VPE0810263 VPE0810265 VPE0810260 475775 VPE0810273 VPE0810251 VPE0805256 VPE0805254 VPE0902324 VPE0810274 VPE0810231 VPE0805258 282339 VPE0810269 VPE0810268 5080108738 VPE0810279 VPE0810278 VPE0902331 VPE0810276 VPE0902328 475779 VPE0902321 VPE0902330 VPE0902325 289057 VPE0805249 5080121963 475781 475780 291238 VPE0902341 5080110317 VPE0810267 475777 VPE0902342 VPE0902343 N/A 475782 VPE0810270 VPE0810271 VPE0810272 5080109661 5090110050 VPE0810257 VPE0810258 340517 VPE0902323 VPE0902327 VPE0902346 VPE0810277 VPE0810252 VPE0902322 VPE0902326 VPE0810241 VPE0902350 VPE0902351 VPE0902332 VPE0902333 5080123443 VPE0902336 296588 5080110678 VPE0902344 VPE0902356 VPE0902366 437930 VPE0902358 VPE0906375 VPE0902355 5080111259 5080110902 5080111518 5080111291 VPE0902352 VPE0810280 VPE0906398 VPE0902369 VPE0906399 VPE0906402 VPE0906404 VPE0906407 VPE0906406 VPE0906405 VPE0906403 VPE0906395 VPE0902340 VPE0906414 VPE0906413 VPE0906410 VPE0906409 VPE0906408 VPE0906418 VPE0906411 VPE0906401 VPE0908446 284646 VPE1003627 VPE0906412 VPE0902361 VPE0902362 VPE0908452 VPE0908454 VPE0908451 VPE0908453 VPE0906415 VPE0810266 VPE0908455 VPE0906419 VPE0908449 VPE0902357 VPE0908464 VPE0911550 VPE1211042 VPE0810249 VPE0908471 VPE0908468 VPE0908469 VPE0906392 VPE0908470 VPE0908475 5090111103 5090109567 VPE0908476 461428 461440 VPE0908483 VPE0908486 VPE0908485 VPE0908484 5080113111 vpe0906379 VPE0908477 VPE0707075 VPE0908448 VPE0908461 VPE0902364 VPE0902365 VPE1006710 VPE0908493 VPE0908492 VPE0906381 VPE0906385 vpe0906380 VPE0902338 VPE0906383 VPE0906396 VPE0908466 5090112193 338859 VPE0908488 VPE0906371 VPE0908495 VPE0908494 VPE0911536 VPE0911537 5080114088 339919 5080113723 VPE0911549 338748 319150 VPE0911547 VPE0908490 UNK427081 338340 VPE0906389 VPE0906387 VPE0911542 VPE0911543 VPE0911544 VPE0911552 VPE0911553 343828 5090104751 VPE0906382 5080114924 VPE0908463 VPE0906394 VPE0906372 VPE0908472 341872 VPE0609165 5090110107 VPE0908474 5080115106 5080115157 VESADLCC1210039 5080115203 VESADLCC1109027 5080115168 VPE0911560 VPE0906391 VPE0906377 VPE0908450 VPE0911558 VPE0911538 VPE0911555 VPE0911557 vpe0906384 5090114080 5080121068 5080118768 5080119713 VPE1105788 5080117079 5080119195 5090105332 5080120576 5090103372 5080122951 VPE1202982 5090106452 474664 5090106371 545904 5080121432 5080119632 475636 5080120886 5080122013 VPE1003608 5090106940 5080119403 5090102082 446718 437923 5090107572 519375 484039 5080116544 450761 5080119527 5090101981 5090106959 494538 5080122617 5090109966 VPE1006731 5080119292 5080117834 5080117958 5090103666 5080118725 5080118539 438767 5080117494 431897 5090111936 554211 5080119705 VESADLCC1012009 5080119020 N/A 5090106649 5080119004 VESADLCC1201028 5090106134 VPE0805265 5090111111 5090109877 5090106630 5090109508 5080123273 5080116889 5090106576 VPE1108848 5090106479 5090106460 5090109648 5090105405 VPE0906373 VPE0906374 VPE0906376 vpe0906378 VPE0906386 VPE0906388 VPE0906390 VPE0906393 VPE0906397 VPE1202990 VPE1202975 VPE0908456 VPE0908465 VPE0908478 VPE0908479 VPE0908489 VPE0911539 VPE0911540 VPE0911541 VPE0911545 VPE1006716 VPE1006717 VPE0911548 VPE0911554 5090102732 5090102694 504277 VPE0911561 VPE0911563 5080118032 5080116986 5080118598 VPE0911564 5080116781 5080117648 5080116692 5090106789 5090106797 Included 5090108560 5090114234 VPE1202973 5040227256 5080122765 5090113491 5080119241 VESADLCC1206035 5090109885 5090108676 5090109389 5090111928 5090110069 5080122374 VESADLCC1109025 5090112754 VPE1112923 5090103364 360284 Included 475637 VPE1003664 5090103151 351974 VPE0911569 VPE0911568 VPE0911567 VPE0911571 372164 VPE0911565 VPE0911574 5090112762 353506 5080117508 VPE0911575 VPE1003613 355793 464080 355444 359032 355475 VPE0911579 VPE0911578 VPE0911581 VPE0911577 LTB0906007 VPE0911583 VPE1111914 VPE0911584 VPE0911585 514726 VPE1003606 VPE1003609 VPE1003611 VPE1003610 513852 513840 VPE1003614 5080117184 VESADLCC1206032 397523 360575 VPE0911573 360601 363544 410336 363529 363514 5090101973 LTB0906003 LTB0906004 LTB0906002 LTB0906005 LTB0906006 VPE1003617 VPE1003616 VPE1003618 365214 365126 VPE1003628 5080118490 372915 VPE1003621 VPE1003622 372096 372081 372053 372066 VPE1003620 VPE1003623 372038 372023 VPE1003626 375819 VPE1003656 375644 375657 5080117982 VPE1003679 5090112916 VPE1003660 VPE1003669 VPE1003667 VPE1003670 VPE1003668 VPE1006707 VPE1003680 VPE1003658 VPE1003662 5080118474 382447 417575 VPE1003663 VPE1006706 VPE1003673 VPE1003665 5080118385 5080122005 5080118504 VPE1003678 390954 5080121858 388370 VPE1006708 5080119608 5080118547 415800 429562 429547 5080119942 VPE1006709 5080119373 412268 5080119829 VPE1006711 452873 5090106614 5080121637 5090102791 VPE1006715 5080121602 VPE1006712 VPE1006728 VPE1006714 VPE1006735 5080119489 VPE1006721 402957 402985 402971 VPE1006727 399363 VPE1006726 VPE1003677 VPE1003675 VPE1003676 VPE1003672 5080119837 VPE1006734 VPE1006729 5090103402 VPE1006724 VPE1006725 VPE1006723 VPE1011771 VPE1006737 VPE1006736 VPE1006738 5090111332 5080123419 407839 VPE1006739 VPE1006740 409022 VPE1210010 VPE1006742 VPE1006741 VPE1006745 VPE0911546 VPE1006744 VPE1006743 5090111901 413002 VPE1006746 VPE1006749 VPE1006748 VPE1006750 414724 419596 VPE1006754 VPE1006753 5080121823 5080121661 416697 5080122676 5080121629 425576 VPE1011759 VPE1011758 421879 421893 VPE1011760 VPE1011762 VPE1011769 425476 VPE1011767 VPE1011770 430684 430196 5090103674 VPE1003607 VPE0911556 5080123427 441335 5090112819 5090107009 434482 5090102783 VPE1011774 VPE1011776 437322 VPE1011775 VPE1011781 VPE1011778 VPE1011779 VPE1003674 5080123435 UPGD1103006BRNPERF2D VPE1011782 443101 VPE1011777 VPE1011783 5090101957 444530 443538 5090104131 5090103410 447422 VPE1011785 VPE1011784 LTB1109018 LTB1109017 LTB1109016 LTB1109015 LTB1109014 LTB1109013 LTB1109012 LTB1109019 LTB1109011 VPE1211028 456950 VPE1003615 VPE1006733 452361 452257 452244 5090104123 VPE1105789 452928 452835 VPE1011766 LTB0906008 LTB0906009 5090106517 VPE1011761 5090113114 5090102635 428096 5090102856 LTB0906010 VPE1105786 5090106436 5090106444 VPE1105787 466262 VPE1011780 VPE1105790 VPE1105796 VPE1105793 VPE1105794 VPE1108807 VPE1202960 VPE1105801 VPE1105798 VPE1105800 VPE1105799 VPE1202957 VPE1108806 5090104425 5090111324 VPE1105803 VPE1105804 VPE1105802 VPE1112939 VPE1105805 VPE1108812 VPE1108811 VPE1108809 VPE1108813 VPE1108814 VPE1108815 VPE1108817 VPE1108816 VPE1108810 VPE1108845 VPE1211034 VPE1108808 VPE1108846 VPE1202974 VPE1108852 VPE1108851 VPE1112920 VPE1108849 VPE1108855 VPE1108856 5090105472 VPE1108859 477819 VPE1108861 479474 VPE1109876 VPE1108864 VPE1109870 VPE1108869 VPE1109871 VPE1109872 VPE1109873 VPE1108862 VPE1108863 VPE1108865 VPE1112941 VPE1108867 VPE1210017 VPE1109887 VPE1109886 VPE1109875 VPE1109888 VPE1108866 VPE1109878 VPE1108858 5090107122 LTB1109020 VPE1105795 VPE1108860 LTB1109025 VPE1112931 VPE1202953 VPE1105797 5090104506 VPE1109879 VPE1109880 5090106541 VPE1109884 492454 VPE1108818 488764 VPE1109881 486480 VPE1210022 487048 VPE1109885 VPE1108853 VPE1108854 VPE1108857 VPE1202963 VPE1202976 VPE1211038 VPE1112945 VPE1202958 VPE1202965 VPE1109883 VPE1109889 VPE1109882 VPE1109891 VPE1109893 VPE1109890 VPE1109892 VPE1111903 VPE1111904 5090106665 VPE1109894 VPE1111895 VPE1111896 VPE1111897 VPE1111898 VPE1111899 VPE1111900 VPE1111901 493457 493445 VPE1111910 VPE1111909 5090106622 5090108374 5090108374 5090108323 VPE1111902 5090111618 VPE1111905 VPE1111906 VPE1111908 VPE1111907 493485 VPE1111912 VPE1111911 494501 494481 494469 5090106355 VPE1111916 VPE1111917 VPE1111918 VPE1111919 VPE1111915 VPE1208003 VPE1112925 495786 VPE1112922 5090109095 VPE1112924 LTB1109021 5090111197 506159 5090107351 505408 504297 VPE1112934 VPE1202961 VPE1112928 VPE1108850 VPE1112929 511685 511699 VPE1112943 VPE1112935 VPE1112936 VPE1112937 VPE1112938 VPE1112940 VPE1112942 5090111820 VPE1112944 VPE1202962 VPE1202959 VPE1202947 VPE1202956 VPE1202966 5090108463 VPE1112946 VPE1202967 513806 513794 5090108951 515369 VPE1202950 VPE1202951 VPE1202952 VPE1202954 VPE1112932 520330 5080120959 519628 531591 VPE1202969 5090109141 5090109125 5090110220 524081 VPE1112930 VPE1202971 VPE1202948 VPE1105792 VPE1202970 VPE1006720 VPE1202972 VPE1202949 5090114374 5090114382 VPE1202955 5090111340 530311 530323 5090110395 LTB1109022 5090109850 VPE1202978 5090111405 VPE1202979 5090110182 VPE1202987 VPE1202985 VPE1202984 5090110301 VPE1202986 LTB1109023 5090110441 5090110441 5090110433 VPE1202989 539078 545412 VPE1112926 5090111839 544262 544250 544279 551765 545203 LTB1109026 VPE1210015 VPE1208002 5090111464 5090111189 5090113149 LTB1109024 551639 551690 VPE1202993 VPE1202995 VPE1202994 VPE1208000 VPE1202996 VPE1208004 552065 552049 VPE1208001 550512 5090112711 VPE1109874 VPE1105791 5090112940 5090112959 549260 VPE1210012 VPE1210014 VPE1210013 VPE1210016 VPE1208005 VPE1208009 VPE1208006 VPE1208007 VPE1208008 VPE1210011 VPE1210019 VPE1210018 VPE1210021 5090112738 5090113408 5090112967 VPE1210020 5090113386 VPE1210023 VPE1211024 VPE1211026 VPE1211027 LTB1212081 5090114358 VPE1211029 5090113807 VPE1211030 VPE1211031 VPE1211033 VPE1211036 VPE1211032 VPE1211035 VPE1211044 VPE1211045 VPE1211043 VPE1211037 VPE1211039 VPE1211040
ClassificationClass II
Reason for RecallVital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
Product Quantity1,978
Recall NumberZ-1181-2013

Class II Devices Event

Event ID64859
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEncore Medical, Lp
CityAustin
StateTX
CountryUS
Distribution PatternUS Distribution to the state of California and International Distribution to the country of Venezuela.
 

Associated Products

Product Description3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Code InfoModel/Catalog Number 391-15-708. Lot/Serial Number 59602230.
ClassificationClass II
Reason for RecallU.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
Product Quantity5
Recall NumberZ-1213-2013

Class II Devices Event

Event ID64860
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.
 

Associated Products

Product DescriptionHeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Code InfoSerial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
ClassificationClass II
Reason for RecallDevice may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
Product Quantity64972
Recall NumberZ-1189-2013

Class II Devices Event

Event ID64868
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCovidien LLC
CityMansfield
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
 

Associated Products

Product DescriptionMedi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Code InfoLot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X
ClassificationClass II
Reason for RecallDefibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Product Quantity133470 (sets of 2)
Recall NumberZ-1184-2013
Product DescriptionMedi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Code InfoLot Numbers: 228651, 232146, 235646X, 301833X, 303928X
ClassificationClass II
Reason for RecallDefibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Product Quantity7485 (sets of 2)
Recall NumberZ-1185-2013

Class II Drugs Event

Event ID64869
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public
Recalling FirmJubilant Cadista Pharmaceuticals Inc.
CitySalisbury
StateMD
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Code InfoLot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
ClassificationClass II
Reason for RecallcGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Product Quantity12770 bottles
Recall NumberD-296-2013

Class II Devices Event

Event ID64885
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
 

Associated Products

Product DescriptionMSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Code Info01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001; 10082010-001; 10142009-001; 10182010-001; 10222010-001; 10252009-001; 10312010-001; 11162010-001; 11242009-001; 11292010-001; 12052010-001; 12072009-001; 12142009-001; 12152009-001; 12162008-001; 12182008-001; 12222010-001
ClassificationClass II
Reason for RecallCoolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Product Quantity70
Recall NumberZ-1211-2013
Product DescriptionOptima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Code Info08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001
ClassificationClass II
Reason for RecallCoolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Product Quantity81
Recall NumberZ-1212-2013

Class II Devices Event

Event ID64889
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.
 

Associated Products

Product DescriptionGE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Code InfoSerial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 00000419280CN3 00000419390CN0 00000419526CN9 00000419525CN1 00000419559CN0 00000418819CN9 00000419506CN1 00000418402CN4 00000419089CN8 00000419550CN9 00000416736CN7 00000418656CN5 00000416781CN3 00000416798CN7 00000418357CN0 00000419447CN8 00000416552CN8 00000418810CN8 00000416764CN9 00000419178CN9 00000417719CN2 00000416389CN5 00000418514CN6 00000417634CN3 00000416848CN0 00000417733CN3 00000417716CN8 00000416849CN8 00000417649CN1 00000416286CN3 00000416401CN8 00000418847CN0 00000419177CN1 00000416533CN8 00000417644CN2 00000419376CN9 00000419504CN6 00000416231CN9 00000416301CN0 00000417626CN9 00000418403CN2 00000419079CN9 00000416268CN1 00000416620CN3 00000416597CN3 00000416763CN1 00000418780CN3 00000417643CN4 00000416647CN6 00000417642CN6 00000418791CN0 00000416466CN1 00000416388CN7 00000416353CN1 00000417134CN4 00000419241CN5 00000418915CN5 00000419174CN8 00000418818CN1 00000416295CN4 00000417720CN0 00000418846CN2 00000416372CN1 00000416762CN3 00000417714CN3 00000416882CN9 00000417713CN5 00000417725CN9 00000416595CN7 00000418020CN4 00000417734CN1 00000419448CN6 00000417735CN8 00000417787CN9 00000419054CN2 00000417696CN2 00000418932CN0 00000419173CN0 00000418300CN0 00000417717CN6 00000418845CN4 00000419561CN6 00000418696CN1 00000418848CN8 00000366477CN8 00000220652HM2 00000421152CN0 00000419040CN1 00000418844CN7 00000416202CN0 00000419391CN8 00000416371CN3 00000418781CN1 00000416814CN2 00000416593CN2 00000416200CN4 00000416739CN1 00000416465CN3 00000416670CN8 00000416881CN1 00000416525CN4 00000416284CN8 00000416796CN1 00000418943CN7 00000419039CN3
ClassificationClass II
Reason for RecallFastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.
Product Quantity166
Recall NumberZ-1188-2013

Class II Devices Event

Event ID64918
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
 

Associated Products

Product DescriptionGE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
Code InfoMfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294098MR9 00000294280MR3 00000294472MR6 00000294494MR0 00000294556MR6 00000294576MR4 00000294643MR2 00000294665MR5 00000294718MR2 00000294913MR9 00000294953MR5 00000295024MR4 00000295092MR1 00000295112MR7 00000295134MR1 00000295215MR8 00000295228MR1 00000295241MR4 00000295506MR0 00000295904MR7 00000296014MR4 00000296046MR6 00000296070MR6 00000296096MR1 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296307MR2 00000296369MR2 00000296418MR7 00000296429MR4 00000296461MR7 00000296462MR5 00000296469MR0 00000296512MR7 00000296517MR6 00000296573MR9 00000296595MR2 00000296602MR6 00000296626MR5 00000296640MR6 00000296821MR2 00000296829MR5 00000296840MR2 00000296860MR0 00000296888MR1 00000296894MR9 00000296908MR7 00000297006MR9 00000297134MR9 00000297147MR1 00000297355MR0 00000297374MR1 00000297387MR3 00000297469MR9 00000297493MR9 00000297624MR9 00000297649MR6 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298083MR7 00000298181MR9 00000298247MR8 00000298248MR6 00000298249MR4 00000298283MR3 00000298310MR4 00000298334MR4 00000298386MR4 00000298387MR2 00000298399MR7 00000298474MR8 00000298494MR6 00000298512MR5 00000298535MR6 00000298537MR2 00000298552MR1 00000298573MR7 00000298574MR5 00000298580MR2 00000298591MR9 00000298655MR2 00000298656MR0 00000298675MR0 00000298677MR6 00000298722MR0 00000298727MR9 00000298738MR6 00000298834MR3 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298907MR7 00000298908MR5 00000298932MR5 00000298943MR2 00000298959MR8 00000298981MR2 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299181MR8 00000299199MR0 00000299200MR6 00000299213MR9 00000299230MR3 00000299250MR1 00000299291MR5 00000299294MR9 00000299320MR2 00000299321MR0 00000299329MR3 00000299331MR9 00000299406MR9 00000299411MR9 00000299491MR1 00000299503MR3 00000299520MR7 00000299522MR3 00000299544MR7 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299644MR5 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299852MR4 00000299908MR4 00000299952MR2 00000299966MR2 00000299967MR0 00000300038MR7 00000300039MR5 00000300122MR9 00000300296MR1 00000300473MR6 00000300493MR4 00000300494MR2 00000300562MR6 00000300564MR2 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300671MR5 00000300687MR1 00000300688MR9 00000300704MR4 00000300713MR5 00000300722MR6 00000300723MR4 00000300724MR2 00000300765MR5 00000300793MR7 00000300794MR5 00000300795MR2 00000300847MR1 00000300867MR9 00000300898MR4 00000300900MR8 00000300929MR7 00000300967MR7 00000300968MR5 00000300987MR5 00000301046MR9 00000301094MR9 00000301126MR9 00000301156MR6 00000301189MR7 00000301190MR5 00000301228MR3 00000301235MR8 00000301260MR6 00000301262MR2 00000301292MR9 00000301295MR2 00000301309MR1 00000301379MR4 00000301380MR2 00000301401MR6 00000301469MR3 00000301522MR9 00000301599MR7 00000301820MR7 00000301822MR3 00000301843MR9 00000301866MR0 00000301869MR4 00000301926MR2 00000301962MR7 00000302193MR8 00000302194MR6 00000302433MR8 00000302434MR6 00000302492MR4 00000302494MR0 00000302545MR9 00000302570MR7 00000302631MR7 00000302633MR3 00000302712MR5 00000302748MR9 00000302997MR2 00000303041MR8 00000303310MR7 00000303322MR2 00000303356MR0 00000303375MR0 00000303377MR6 0 1 151 151545 292879 1537343 00000002143YR6 00000005215TR9 00000005216YR7 00000005232YR4 00000005233YR2 00000005526YR9 00000005536YR8 00000005538YR4 00000005542YR6 00000005545YR9 00000005551YR7 00000005555YR8 00000005564YR0 00000005568YR1 00000005573YR1 00000005965YR9 00000005976YR6 00000005984YR0 00000005992YR3 00000006556YR5 00000006558YR1 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00000007863YR4 00000007864YR2 00000007865YR9 00000007866YR7 00000007867YR5 00000007871YR7 00000007879YR0 00000007880YR8 00000007882YR4 00000007884YR0 00000007886YR5 00000007887YR3 00000007892YR3 00000008059YR8 00000008061YR4 00000008063YR0 00000008198YR4 00000008332YR9 00000008335YR2 00000008342YR8 00000008345YR1 00000008349YR3 00000008352YR7 00000008359YR2 00000008367YR5 00000008369YR1 00000008372YR5 00000008374YR1 00000008378YR2 00000008380YR8 00000008387YR3 00000008391YR5 00000008392YR3 00000008396YR4 00000008397YR2 00000008398YR0 00000008403YR8 00000008515YR9 00000008516YR7 00000008518YR3 00000008520YR9 00000008521YR7 00000008524YR1 00000008530YR8 00000008536YR5 00000008539YR9 00000008541YR5 00000008543YR1 00000008545YR6 00000008546YR4 00000008548YR0 00000008551YR4 00000008553YR0 00000008556YR3 00000008558YR9 00000009003YR5 00000009005YR0 00000009007YR6 00000009008YR4 00000009012YR6 00000009014YR2 00000009020YR9 00000009021YR7 00000009026YR6 00000009028YR2 00000009034YR0 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ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.
Product Quantity4338
Recall NumberZ-1207-2013
Product DescriptionGE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
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00000013304YR1 00000013307YR4 00000013376YR9 00000010229YR3 00000014211YR7 00000012083YR2 00000013179YR7 00000012328YR1 00000012990YR8 00000013450YR2 00000014753YR8 00000015001YR1 00000006527YR6 00000006547YR4 00000011532YR9 00000013382YR7 00000013623YR4 00000013627YR5 00000013628YR3 00000013703YR4 00000013807YR3 00000014061YR6 00000014064YR0 00000010252YR5 00000012797YR7 00000005072YR4 00000005074YR0 00000006203YR4 00000006510YR2 00000006511YR0 00000006523YR5 00000006530YR0 00000006533YR4 00000006534YR2 00000006541YR7 00000006542YR5 00000006543YR3 00000006553YR2 00000006554YR0 00000010939YR7 00000010976YR9 00000012552YR6 00000012553YR4 00000012574YR0 00000012793YR6 00000012794YR4 00000012878YR5 00000012996YR5 00000013058YR3 00000013059YR1 00000013204YR3 00000013378YR5 00000013629YR1 00000013757YR0 00000014328YR9 00000014417YR0 00000014456YR8 00000011838YR0 00000006199YR4 00000010115YR4 00000011536YR0 00000012290YR3 00000014518YR5 00000015533YR3 00000015534YR1 00000015535YR8 00000015536YR6 00000015576YR2 00000015577YR0 00000015578YR8 00000015579YR6 00000015632YR3 00000015644YR8 00000015687YR7 00000015688YR5 00000015693YR5 00000015694YR3 00000015725YR5 00000015746YR1 00000015868YR3 00000006175YR4 00000006195YR2 00000008700YR7 00000008722YR1 00000008724YR7 00000010581YR7 00000011496YR7 00000011668YR1 00000012101YR2 00000012145YR9 00000012146YR7 00000012149YR1 00000012792YR8 00000013308YR2 00000014065YR7 00000014458YR4 00000014622YR5 00000014621YR7
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.
Product Quantity822 (154 US; 668 OUS)
Recall NumberZ-1208-2013
Product DescriptionGE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
Code InfoMfg Lot or Serial # 284481HM9 283390HM3 282416HM7 300218HM5 296431HM0 294361HM1 296436HM9 278690HM3 285914HM8 300212HM8 302728HM1 286892HM5 294373HM6 284475HM1 274212HM0 294150HM8 286871HM9 285458HM6 285464HM4 285905HM6 286889HM1 289113HM3 290003HM3 290018HM1 295187HM9 295708HM2 297795HM7 298512HM5 298518HM2 300206HM0 300209HM4 300905HM7 300911HM5 305123HM2 305132HM3 305141HM4 305300HM6 305303HM0 306320HM3 307364HM0 307373HM1 307376HM4 308186HM6 308923HM2 309476HM0 202350HM5 213385HM8 226223HM6 238928HM6 241057HM9 266117HM1 176965HM2 179337HM1 201787HM9 229961HM8 274239HM3 274891HM1 302722HM4 271715HM5 273786HM4 190565HM2 263639HM7 190926HM6 191138HM7 203039HM3 208218HM8 242119HM6 262861HM8 239003HM7 173924HM2 223179HM3 200595HM7 220569HM8 200583HM3 237533HM5 202684HM7 227617HM8 231629HM7 289983HM9 257774HM0 295726HM4 301810HM8 282422HM5 286886HM7 274218HM7 267655HM9 210567HM4 286868HM5 263617HM3 266951HM3 254615HM8 187938HM6 196629HM0 238231HM5 282404HM3 167486HM0 199901HM0 193891HM9 173912HM7 170636HM5 294147HM4 244336HM4 292524HM6 179350HM4 170947HM6 233942HM2 162548HM2 293800HM9 227765HM5 286874HM3 230345HM1 174556HM1 213014HM4 192701HM1 238597HM9 184917HM3 268113HM8 221655HM4 254616HM6 269129HM3 283384HM6 281434HM1 283387HM9 285455HM2 285449HM5 250051HM0 265004HM2 257789HM8 256150HM4 235822HM4 176555HM1 206273HM5 264194HM2 267204HM6 293080HM8 262350HM2 268124HM5 211504HM6 195579HM8 202478HM4 252485HM8 187478HM3 297798HM1 285461HM0 267698HM9 249448HM2 286027HM8 260953HM5 210554HM2 265012HM5 193026HM2 211535HM0 269423HM0 172347HM7 266962HM0 195447HM8 262850HM1 294144HM1 206272HM7 267685HM6 170573HM0 173420HM1 293095HM6 195469HM2 226804HM3 222527HM4 208276HM6 241705HM3 297318HM8 297813HM8 237249HM8 187075HM7 170080HM6 294141HM7 186769HM6 297816HM1 293809HM0 208920HM9 247326HM2 293803HM3 172348HM5 298503HM4 237600HM2 191146HM0 286030HM2 296445HM0 247348HM6 187173HM0 238213HM3 292530HM3 295717HM3 297303HM0 297789HM0 307336HM8 307351HM7 307354HM1 307367HM3 307379HM8 308180HM9 308907HM5 202345HM5 204158HM0 205908HM7 206819HM5 210513HM8 213193HM6 214041HM6 214712HM2 215676HM8 216125HM5 217358HM1 218474HM5 219406HM6 223599HM2 224698HM1 224707HM0 229042HM7 230858HM3 231784HM0 234987HM6 242129HM5 243112HM0 244329HM9 245315HM7 250988HM3 252871HM9 256318HM7 265044HM8 267712HM8 271741HM1 305144HM8 305150HM5 305312HM1 305321HM2 305845HM0 306311HM2 306314HM6 307370HM7 308183HM3 219021HM3 222105HM9 228098HM0 245639HM0 257108HM1 262327HM0 305833HM6 305836HM9 308915HM8 185938HM8 189596HM0 228549HM2 230620HM7 230848HM4 245161HM5 245629HM1 245857HM8 249436HM7 255984HM7 273783HM1 203048HM4 165776HM6 286655HM6 240141HM2 168931HM4 188073HM1 224463HM0 247337HM9 254973HM1 199889HM7 191893HM7 168298HM8 263628HM0 250039HM5 269994HM0 252414HM8 252417HM1 282419HM1 250054HM4 271721HM3 250042HM9 252422HM1 280553HM9 289380HM8 290009HM0 290012HM4 290015HM7 295720HM7 297804HM7 300215HM1 300221HM9 302713HM3 302719HM0 305126HM5 305135HM6 305138HM0 305309HM7 306418HM5 306421HM9 306424HM3 307361HM6 308527HM1 308531HM3 308920HM8 218302HM8 271724HM7 276201HM1 281225HM3 168057HM8 170946HM8 186296HM0 188082HM2 189689HM3 205587HM9 205674HM5 212413HM9 270536HM6 271417HM8 282428HM2 282431HM6 267658HM3 289110HM9 297807HM0 274221HM1 242952HM0 289100HM0 285452HM9 282425HM8 263670HM2 263682HM7 297810HM4 307382HM2 212655HM5 269453HM7 271611HM6 273792HM2 278693HM7 281437HM4 225162HM7 169412HM4 187748HM9 300908HM1 175854HM9 186765HM4 187012HM0 289116HM6 296428HM6 297315HM4 210900HM7 217759HM0 267201HM2 236458HM6 184419HM0 269418HM0 293794HM4 219128HM6 257819HM3 210890HM0 192199HM8 178541HM9 193224HM3 281419HM2 179953HM5 242143HM6 269409HM9 229427HM0 261011HM1 265007HM5 267652HM6 261005HM3 250465HM2 257783HM1 276180HM7 293127HM7 266900HM0 185390HM2 259654HM2 293092HM3 187162HM3 250459HM5 267643HM5 293130HM1 280902HM8 283381HM2 245745HM5 257792HM2 196358HM6 265001HM8 252375HM1 261008HM7 245624HM2 269309HM1 267646HM8 257780HM7 293089HM9 193207HM8 252396HM7 295723HM1 296425HM2 297321HM2 297792HM4 298506HM7 298509HM1 298515HM8 305147HM1 306415HM1 307327HM7 307330HM1 307333HM5 305842HM7 182226HM1 187469HM2 188934HM4 254619HM0 291203HM8 305318HM8 306308HM8 188814HM8 265023HM2 189945HM9 256448HM2 259663HM3 305306HM3 291784HM7 204173HM9 289103HM4 261730HM6 300914HM9 181534HM9 221022HM7 217783HM0 192378HM8 280559HM6 208928HM2 193130HM2 177380HM3 305129HM9 247878HM2 198004HM4 198790HM8 224716HM1 245556HM6 274215HM3 280905HM1 281443HM2 309473HM7 197709HM9 259648HM4 223609HM9 264183HM5 281277HM4 224451HM5 249456HM5 196791HM8 216112HM3 235831HM5 259410HM9 245748HM9 185608HM7 214982HM1 230838HM5 263688HM4 256433HM4 262310HM6 268809HM1 168747HM4 194588HM0 202467HM7 278684HM6 281428HM3 286880HM0 299936HM5 300200HM3 167093HM4 241081HM9 284466HM0 229562HM4 262295HM9 259420HM8 252402HM3 276192HM2 261736HM3 264992HM9 175009HM0 176123HM8 176952HM0 194652HM4 206783HM3 210539HM3 213393HM2 224442HM4 226020HM6 230214HM9 293118HM6 294820HM6 266894HM5 266897HM8 271733HM8 281440HM8 291778HM9 281431HM7 263673HM6 261733HM0 182601HM5 200902HM5 205894HM9 226420HM8 226780HM5 252497HM3 297822HM9 252393HM4 256141HM3 257771HM6 257798HM9 207286HM6 264554HM7 286898HM2 286901HM4 212641HM5 236222HM6 256156HM1 257768HM2 165275HM9 252380HM1 256424HM3 263676HM9 276207HM8 290033HM0 248583HM7 250462HM9 264983HM8 175614HM7 206808HM8 264586HM9 262298HM3 207131HM4 284460HM3 250048HM6 259657HM5 190053HM9 298500HM0 252411HM4 197721HM4 214032HM5 264980HM4 286649HM9 198712HM2 204139HM0 295732HM2 165274HM2 289091HM1 183671HM7 218943HM9 233375HM5 260996HM4 262286HM8 262289HM2 183345HM8 197244HM7 247882HM4 276204HM5 278687HM9 285902HM3 264986HM1 264998HM6 280556HM2 290036HM3 293812HM4 297819HM5 300197HM1 250057HM7 184795HM3 270513HM5 271706HM4 295729HM8 297324HM6 252408HM0 216086HM9 293121HM0 257777HM3 276210HM2 278672HM1 281425HM9 284463HM7 285911HM4 289096HM0 297306HM3 297327HM9 242138HM6 223718HM8 263691HM8 228528HM6 256153HM8 282413HM4 292521HM2 300203HM7 301816HM5 301819HM9 302734HM9 302737HM2 305153HM9 305156HM2 308177HM5 308929HM9 309506HM4 309509HM8 310727HM3 311241HM4 312231HM4 312379HM1 194662HM3 223449HM0 264205HM6 276198HM9 171699HM2 269456HM0 291215HM2 278675HM4 266903HM4 266906HM7 278678HM8 267634HM4 281422HM6 263685HM0 268812HM5 264989HM5 269447HM9 274224HM5 199733HM7 181103HM3 180699HM1 171698HM4 229582HM2 224689HM0 293124HM4 302716HM6 270510HM1 243170HM8 196395HM8 290030HM6 199942HM4 290024HM9 227474HM4 241065HM2 265034HM9 222113HM3 210288HM7 193196HM3 297801HM3 257843HM3 240130HM5 170081HM4 227429HM8 235191HM4 309470HM3 256144HM7 273789HM8 257546HM2 226814HM2 262319HM7 214907HM8 172794HM0 198684HM3 241050HM4 172560HM5 239726HM3 262304HM9 281416HM8 291206HM1 291209HM5 292527HM9 293083HM2 293086HM5 293133HM5 293806HM6 294367HM8 294370HM2 294814HM9 294817HM2 308912HM5 308926HM5 309479HM4 309482HM8 309491HM9 309494HM3 309497HM6 309500HM7 309503HM1 310697HM8 310700HM0 310703HM4 310706HM7 310709HM1 310712HM5 310715HM8 310718HM2 310721HM6 310724HM0 311119HM2 311122HM6 311125HM9 312210HM8 312213HM2 312216HM5 312219HM9 312222HM3 312225HM6 312228HM0 312349HM4 312352HM8 312355HM1 312358HM5 312361HM9 312364HM3 312367HM6 199950HM7 205562HM2 171317HM1 236450HM3 271730HM4 297309HM7 252405HM6 256430HM0 256455HM7 250045HM2 257786HM4 256147HM0 290021HM5 269450HM3 271712HM2 271718HM9 274227HM8 213022HM7 185947HM9 185369HM6 191521HM4 285908HM0 257543HM9 259651HM8 289383HM2 290006HM6 294364HM5 286895HM8 267649HM2 268806HM7 282407HM6 286652HM3 286877HM6 269444HM6 284469HM4 289978HM9 267640HM1 276189HM8 280562HM0 177222HM7 172802HM1 166315HM2 168297HM0 224432HM5 259738HM3 270004HM5 262313HM0 282410HM0 281222HM0 257549HM6 221033HM4 170572HM2 301813HM2 302725HM7 305839HM3 163410HM4 184411HM7 186185HM5 208913HM4 266888HM7 262307HM2 301929HM6 271727HM0 278696HM0 295714HM0 291212HM9 290027HM2 281446HM5 301932HM0 306317HM9 308535HM4 176776HM3 266891HM1 271414HM5 189107HM6 208937HM3 252399HM1 263679HM3 160222HM6 259660HM9 195460HM1 205666HM1 257825HM0 269412HM3 259666HM6 183780HM6 302710HM9 195287HM8 208285HM7 219747HM3 220369HM3 247222HM3 257835HM9 271709HM8 276195HM5 181957HM2 184081HM8 188801HM5 199883HM0 219988HM3 234932HM2 262316HM3 262301HM5 221645HM5 182786HM4 223171HM0 290000HM9 214718HM9 284478HM5 269415HM6 255972HM2 286883HM4 214477HM2 227440HM5 195590HM5 267637HM7 278681HM2 293797HM7 262292HM6 174879HM7 210062HM6 268815HM8 284472HM8 276186HM4 295711HM6 305315HM4 308523HM0 166009HM1 169411HM6 220560HM7 266909HM1 256427HM6 302731HM5 297312HM1 264995HM2 195286HM0 223710HM5 231594HM3 233074HM4 234970HM2 231164HM5 269434HM7 270507HM7 276183HM1 267661HM7 291781HM3 177221HM9 178471HM9 183327HM6 312428HM6
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.
Product Quantity864 (57 US; 802 OUS)
Recall NumberZ-1209-2013

Class II Devices Event

Event ID64919
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOwens & Minor Distribution, Inc.
CityMechanicsville
StateVA
CountryUS
Distribution PatternUS Nationwide Distribution.
 

Associated Products

Product DescriptionMediChoice® Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
Code InfoItem # Lot# WOD5001 1206DG13A WOD5001 1206DG13B WOD5001 1207DG13A WOD5001 1208DG13A WOD5001 1209DG13A WOD5001 1210DG13A/B WOD5001 1211DG13A WOD5001 1212DG13A WOD5001 1301DG13A WOD5001 1303DG13A WOD5002 1206DG14A WOD5002 1208DG14A WOD5002 1209DG14A WOD5002 1211DG14A Expiration Dates: 2017-05, 2017-06, 2017-06, 2017-07, 2017-08, 2017-09, 2017-10, 2017-11, 2018-02.
ClassificationClass II
Reason for RecallOwens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
Product Quantity4298.5 cases
Recall NumberZ-1192-2013

Class II Devices Event

Event ID64942
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
 

Associated Products

Product DescriptionStryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."
Code InfoCatalog number 703615
ClassificationClass II
Reason for RecallStryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
Product Quantity107 units
Recall NumberZ-1210-2013

Class II Devices Event

Event ID64944
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMartinez
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.
 

Associated Products

Product DescriptionSoftware correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code InfoSyngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754
ClassificationClass II
Reason for RecallSoftware update to fix multiple safety related issues.
Product Quantity245 active devices
Recall NumberZ-1182-2013

Class II Veterinary Event

Event ID64956
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternShipped to one distibutor, Putney Inc in Maine. No foreign, military, or government consignees.
 

Associated Products

Product DescriptionAmoxicillin Capsules, USP, 500mg, 500 count bottles, NDC 26637-222-50.
Code InfoLot CS2959, Expiry 07-2015, NDC 26637-222-50.
ClassificationClass II
Reason for RecallSandoz is recalling certain lots of Amoxicillin Capsules, USP 500mg due to potential contamination with fragments of stainless steel wire mesh.
Product Quantity1458 bottles of 500 capsules each
Recall NumberV-146-2013

Class II Drugs Event

Event ID64963
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTarmac Products, Inc. d.b.a. Axara Pharmaceuticals
CityMiami Gardens
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
Code InfoLot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Product Quantity13,369 bottles (12oz), 2607 bottles (26oz)
Recall NumberD-311-2013

Class II Devices Event

Event ID64972
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.
 

Associated Products

Product DescriptionSTERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Code InfoLot Codes: 025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 038127 039127 040127 041121 042127 043127 044127 045121 046127 047127 048127 049127 052127 053121 053127 054127 055121 056127 057127 058127 059127 060127 061127 062121 062127 063127 064127 065127 067127 068127 069121 070127 071127 072127 073127 076121 081127 082127 084127 085127 086121 086127 087127 089127 090127 091127 092127 093121 094127 095127 100121 100127 101127 102127 104127 107121 107127 107128 109127 109128 110127 111127 114121 118127 121121 121127 122127 123127 124127 125127 128121 128127 129127 130127 131127 132127 135121 135127 136127 137127 156121 156127 158127 159127 160127 163121 163127 164127 165127 13912706 18112706 18412706 18512706 18712706 18812706 19012706 19212706 19312706 19412706 19512706 19712706 19812106 19912706 20012106 20112706 20212706 20512106 20512706 20612106 20612706 20712706 20812106 20812706 21212106 21212706 21312106 21312706 21412706 21512106 21512806 21612106 21812706 21912706 22012106 22112706 22212706 22312706 22612106 22612706 22712706 22812106 22812706 22912706 23012106 23012706 23112706 23312106 23312706 23412706 23512106 23512706 23612706 23712106 23712706 23812706 24012106 24012706 24112706 24212106 24212706 24312706 24412706 24812106 24812706 24912106 24912706 25012706 25112706 25412106 25412706 25512106 25512706 25612106 25812106 25812706 25912706 26112106 26212706 26312106 26312706 26812106 26812706 30112706
ClassificationClass II
Reason for RecallAdvanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
Product Quantity69,994 cases
Recall NumberZ-1180-2013

Class III Biologics Event

Event ID44031
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Dec-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info01FJ07492A; 01FJ07492B;01FJ07493A; 01FJ07493B; 01FJ07494A; 01FJ07494B
ClassificationClass III
Reason for RecallBlood products, which may have been transported under unacceptable temperatures after collection, were distributed.
Product Quantity6
Recall NumberB-0736-13

Class III Biologics Event

Event ID46647
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info9929659
ClassificationClass III
Reason for RecallBlood product, that was irradiated twice, was distributed
Product Quantity1 Unit
Recall NumberB-0779-13

Class III Biologics Event

Event ID49760
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Services LP
CityIndependence
StateMO
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info07IMOG3145;07IMOG3633;07IMOG4399;07IMOG5428; 07IMOG7544;07IMOG8065;07IMOG9727;08IMOA1536; 08IMOA2184;08IMOA3310;08IMOA3940;08IMOA5130; 08IMOA5775;08IMOA6926;08IMOA7545;08IMOA8600; 08IMOA9170;08IMOB0195;08IMOB0120;08IMOB1852; 08IMOB2406;08IMOB3476;08IMOB4110;08IMOB6915; 08IMOB7535;08IMOB8596;08IMOB9162;08IMOC0356; 08IMOC1016;08IMOC2529;08IMOC3217;08IMOC4380; 08IMOC5073;08IMOC6209;08IMOC6880;08IMOC9283; 08IMOC9918;08IMOD1004;08IMOD1628;08IMOD2715; 08IMOD3403
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity41 Units
Recall NumberB-1026-13

Class III Biologics Event

Event ID53628
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Sep-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3740050804; 3740051489;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1204-13

Class III Biologics Event

Event ID54939
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of Alaska, Inc.
CityAnchorage
StateAK
CountryUS
Distribution PatternNew York, Alaska, Louisiana, and Texas.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW066509675798, W066509675749, W066509675728, W066509657517, W066509657518, W066509657532, W066509675814, W066509678095, W066509677794, W066509677801, W066509658117, W066509657524, W066509657540, W066509657556, W066509675781, W066509675730, W066509675741, W066509677810, W066509677815, W066509677433, W066509657515, W066509657558, W066509675892, W066S09675808, W066509675793 , W066509675802, W066509675804, W066509657532, W066509675692, W066509658672, W066509658119.
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed..
Product Quantity31 components
Recall NumberB-0811-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW066509658119, W066509675793, W066509677433; W06650975802
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed..
Product Quantity4 components
Recall NumberB-0812-13

Class III Biologics Event

Event ID64121
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Deglycerolized Leukocytes Reduced
Code InfoW117008129536J Part 1; W117008129536J Part 2;
ClassificationClass III
Reason for RecallBlood products, with an unacceptably low red cell recovery rate, were distributed.
Product Quantity2
Recall NumberB-0989-13

Class III Biologics Event

Event ID64126
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican National Red Cross
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info42FR80763; 42S64749;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0994-13

Class III Biologics Event

Event ID64209
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmITXM Clinical Services
CityPittsburgh
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW086712001888; W086712001971;
ClassificationClass III
Reason for RecallBlood products, leukodepleted greater than five days after collection, were distributed.
Product Quantity2
Recall NumberB-1088-13

Class III Drugs Event

Event ID64459
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWarner Chilcott Company LLC
CityFajardo
StatePR
CountryUS
Distribution PatternUS Nationwide and Puerto Rico
 

Associated Products

Product DescriptionFemhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Code Info Lot# 510122B; exp 04/13
ClassificationClass III
Reason for RecallChemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Product Quantity27,509 bottles
Recall NumberD-303-2013
Product DescriptionJevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Code InfoLot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
ClassificationClass III
Reason for RecallChemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Product Quantity17,136 bottles
Recall NumberD-304-2013
Product DescriptionFemhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Code InfoLot# 507694B; exp 02/13
ClassificationClass III
Reason for RecallChemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Product Quantity6,408 bottles
Recall NumberD-305-2013

Class III Drugs Event

Event ID64652
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmReckitt Benckiser Inc
CityParsippany
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
Code Info16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
ClassificationClass III
Reason for RecallSubpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Product Quantity27,718 cases 16 count and 7,551 cases 576 count
Recall NumberD-310-2013

Class III Drugs Event

Event ID65002
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPercocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.
Code InfoLot # 6IHD, Exp 09/30/2013
ClassificationClass III
Reason for RecallPresence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Product Quantity1 bottle
Recall NumberD-301-2013

Class III Drugs Event

Event ID65017
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHi-Tech Pharmacal Co., Inc.
CityAmityville
StateNY
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionAcetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Code InfoLot #: 610593, Exp 06/13
ClassificationClass III
Reason for RecallSubpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Product Quantity11,472 bottles
Recall NumberD-302-2013

Mixed Classification Biologics Event

Event ID50386
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01GJ97127
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1024-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info01GJ97127
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1025-13

Mixed Classification Biologics Event

Event ID57786
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross
CitySalt Lake City
StateUT
CountryUS
Distribution PatternUtah, Nevada, Washington DC, California, North Carolina and Pennsylvania
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info020LE34036, 020LE34040, 020LE34041, 020LE34043, 020LE34044, 020LE34045, 020LE34046, 020LE34048, 020LE34051, 020LE34053, 020LE34054, 020LE34055, 020LE34056, 020LE34059, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34064, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34073, 020LE34074, 020LE34075, 020LE34076, 020LE34077, 020LE34078, 020LE34079, 020LE34080, 020LE34081.
ClassificationClass III
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity36 components
Recall NumberB-1019-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020LE34037 , 020LE34039 , 020LE34041 , 020LE34042 , 020LE34046, 020LE34047, 020LE34048, 020LE34049, 020LE34050, 020LE34051, 020LE34052, 020LE34054, 020LE34056, 020LE34057, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34074, 020LE34076, 020LE34077, 020LE34078,
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity30 components
Recall NumberB-1020-13
Product DescriptionPlasma Frozen Within 24 Hours After Phlebotomy (FP24)
Code Info020LE34038, 020LE34049, 020LE34052, 020LE34057, 020LE34058.
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity5 components
Recall NumberB-1021-13

Mixed Classification Biologics Event

Event ID64166
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternSwaziland; Florida; New York
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036809308115;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1066-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036809816399;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1067-13
Product DescriptionCryoprecipitated AHF
Code InfoW036809819156;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1068-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809308115;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1069-13

Mixed Classification Biologics Event

Event ID64168
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036812581268;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1071-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812845751;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1072-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812581268;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1073-13

Mixed Classification Biologics Event

Event ID64169
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810087981;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1074-13
Product DescriptionCryoprecipitated AHF
Code InfoW036810087981;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1075-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810087981;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1076-13

Mixed Classification Biologics Event

Event ID64170
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNew Zealand; Florida
 

Associated Products

Product DescriptionRed Blood Cells Irradiated
Code InfoW036811130540;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1077-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036811130540; W036812426906;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1078-13
Product DescriptionRed Blood Cells
Code InfoW036812426906;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1079-13

Mixed Classification Food Event

Event ID64945
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPaleteria Y Neveria La Rosita, LLC
CitySouth Bend
StateIN
CountryUS
Distribution PatternDomestic: MI, IN retail stores
 

Associated Products

Product DescriptionPineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1353-2013
Product DescriptionMango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids UPC Code 8 94163 00220 5
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1354-2013
Product DescriptionVanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1355-2013
Product DescriptionSpicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1356-2013
Product DescriptionSpicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1357-2013
Product DescriptionGuava Fruit Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, guava fruit, sugar, tumeric, blue 1, UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1358-2013
Product DescriptionWatermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1359-2013
Product DescriptionPina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder,
Code Infofirm does not code product
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1360-2013
Product DescriptionStrawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40, UPC Code 8 94163 00220 5
Code Infofirm does not code product
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1361-2013
Product DescriptionBubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1362-2013
Product DescriptionStrawberry Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6
Code Infofirm does not code products
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1363-2013
Product DescriptionStrawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4
Code Infofirm does not code products
ClassificationClass III
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1364-2013
Product DescriptionVanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5
Code Infofirm does not code products
ClassificationClass II
Reason for RecallProduct labeling is incorrect, FD&C colors are undeclared.
Product Quantity
Recall NumberF-1365-2013
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