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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Class I Devices Event

Event ID61943
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion 2200 Inc
CityMcGaw Park
StateIL
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
 

Associated Products

Product DescriptionAirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Infoproduct codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
ClassificationClass I
Reason for RecallThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall NumberZ-1899-2012
Product DescriptionAirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Infoproduct codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
ClassificationClass I
Reason for RecallThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall NumberZ-1900-2012
Product DescriptionAirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Code Infoproduct codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
ClassificationClass I
Reason for RecallThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product Quantity
Recall NumberZ-1901-2012

Class I Food Event

Event ID62340
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHannaford Bros.
CityScarborough
StateME
CountryUS
Distribution PatternNH, MA, ME, NY and VT
 

Associated Products

Product DescriptionHannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374
Code InfoProduct sold in retail bakery prior to 6/15/12
ClassificationClass I
Reason for RecallUndeclared egg
Product Quantity990 units
Recall NumberF-1687-2012

Class I Food Event

Event ID62369
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDeep Foods Inc
CityUnion
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCrispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3
Code InfoUPC 627265002176 with best by dates up to March 27, 2013
ClassificationClass I
Reason for RecallProducts may contain undeclared milk.
Product Quantity
Recall NumberF-1720-2012
Product DescriptionCrispy by TWI Foods Coconut Cookies, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5.
Code InfoUPC 627265005214 with best by dates up to March 27, 2013
ClassificationClass I
Reason for RecallProducts may contain undeclared milk.
Product Quantity
Recall NumberF-1721-2012
Product DescriptionCrispy by TWI Foods Almond Cookies, Biscuit, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3
Code InfoUPC 6 27265 005221 6; All codes, best before March 29, 2013.
ClassificationClass I
Reason for RecallProducts may contain undeclared milk.
Product Quantitynot provided.
Recall NumberF-1722-2012
Product DescriptionCrispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 7 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3.
Code InfoUPC 6 27265 00161 2; All codes, best before March 29, 2013.
ClassificationClass I
Reason for RecallProducts may contain undeclared milkand almonds.
Product Quantitynot provided.
Recall NumberF-1723-2012

Class II Biologics Event

Event ID39122
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045007902862
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1754-12

Class II Biologics Event

Event ID40631
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-05
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternSwitzerland, CO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info9049505
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living in an HIV-O risk area, were distributed.
Product Quantity1 unit
Recall NumberB-1742-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info9049505
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living in an HIV-O risk area, were distributed.
Product Quantity1 unit
Recall NumberB-1743-12

Class II Biologics Event

Event ID46033
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternOmaha, NE
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info09GZ09998; 09GZ10010; 09GZ10011
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but did not have leukoreduction testing completed were distributed.
Product Quantity3 units
Recall NumberB-1755-12

Class II Biologics Event

Event ID47955
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmARC Blood Services, New England Region
CityDedham
StateMA
CountryUS
Distribution PatternMA, NY
 

Associated Products

Product DescriptionRed Blood Cells
Code Info004LE80082, 004LE80083, 004LE80084, 004LE80086, 004LE80087, 004LE80095, 004LE80097, 004LE80098, 004LE80099, 004LE80100
ClassificationClass II
Reason for RecallBlood products, collected using equipment that was not validated, were distributed.
Product Quantity10 units
Recall NumberB-2028-12
Product DescriptionFresh Frozen Plasma
Code Info004LE80082, 004LE80083, 004LE80087, 004LE80099
ClassificationClass II
Reason for RecallBlood products, collected using equipment that was not validated, were distributed.
Product Quantity4 units
Recall NumberB-2029-12

Class II Biologics Event

Event ID56083
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityDubuque
StateIA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info09DIAJ5514;09DIAK4140;09DIAK3063;09DIAJ8774;09DIAJ7748;09DIAJ4642;09DIAJ2790;09DIAI8746;09DIAI7925;09DIAI6004;09DIAI4991;09DIAI3181;09DIAI2161;09DIAI0015;09DIAH8793;09DIAH7191;09DIAH5965;09DIAJ1752
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity18 units
Recall NumberB-1747-12

Class II Devices Event

Event ID57350
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPride Mobility Products Corp
CityExeter
StatePA
CountryUS
Distribution PatternWorldwide Distribution
 

Associated Products

Product DescriptionVictory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
Code InfoSC609PS SD514509149FV0 SD514609080FV0 SD514609059FV0 SD514509207FV0 SD514509251FV0 SD514609113FV0 SD514609133FV0 SD514509186FV0 SD514509246FV0 SD520809132FV0 SD514609024FV0 SD514509188FV0 SD514609020FV0 SD502010082030 SD502010080030 SD502010084030 SD514509181FV0 SD514509240FV0 SD514609141FV0 SD514609030FV0 SD525409018030 SD514609005FV0 SD514609007FV0 SD514509194FV0 SD514609119FV0 SD514509222FV0 SD514609135FV0 SD520809138FV0 SD520809037FV0 SD514509211FV0 SD514609009FV0 SD514509197FV0 SD514509164FV0 SD514509223FV0 SD514509195FV0 SD514609067FV0 SD514609034FV0 SD514509210FV0 SD514609081FV0 SD520809048FV0 SD514509171FV0 SD520809076FV0 SD514509153FV0 SD514509156FV0 SD514509160FV0 SD514509231FV0 SD514509250FV0 SD514509157FV0 SD514509151FV0 SD514509150FV0 SD514609112FV0 SD514509169FV0 SD514609106FV0 SD514609087FV0 SD514609116FV0 SD514509176FV0 SD514609120FV0 SD514609013FV0 SD514609118FV0 SD514509274FV0 SD526409032030 SD514609102FV0 SD514609027FV0 SD514609041FV0 SD514609051FV0 SD514609134FV0 SD514509199FV0 SD514609083FV0 SD514609049FV0 SD514609055FV0 SD514609077FV0 SD514509203FV0 SD514509249FV0 SD514509183FV0 SD514509189FV0 SD520809119FV0 SD514609076FV0 SD514509158FV0 SD514509184FV0 SD514609084FV0 SD514509147FV0 SD520809042FV0 SD514509201FV0 SD514609026FV0 SD514509258FV0 SD533509010030 SD514609125FV0 SD514509154FV0 SD514609074FV0 SD514609054FV0 SD514609057FV0 SD520809134FV0 SD514609075FV0 SD514609008FV0 SD514509255FV0 SD514509187FV0 SD514609052FV0 SD514609079FV0 SD514509200FV0 SD514509272FV0 SD514609111FV0 SD514609082FV0 SD514609115FV0 SD514609021FV0 SD514609017FV0 SD514609035FV0 SD514609038FV0 SD514609063FV0 SD514509213FV0 SD514609062FV0 SD514509218FV0 SD514609060FV0 SD514509202FV0 SD514609036FV0 SD514509206FV0 SD514609031FV0 SD514509185FV0 SD514509152FV0 SD514609091FV0 SD514609100FV0 SD514609064FV0 SD514609045FV0 SD514509248FV0 SD514609129FV0 SD514509172FV0 SD514609128FV0 SD514609016FV0 SD514609117FV0 SD514509216FV0 SD514509268FV0 SD514609033FV0 SD514509148FV0 SD514609140FV0 SD520809113FV0 SD514609109FV0 SD514609056FV0 SD502110014030 SD514609122FV0 SD514609043FV0 SD520809136FV0 SD514509196FV0 SD514609078FV0 SD514509205FV0 SD514509243FV0 SD514509275FV0 SD520809041FV0 SD514509229FV0 SD527409028030 SD514609126FV0 SD514609085FV0 SD514609138FV0 SD514609006FV0 SD520809100FV0 SD514609028FV0 SD514609010FV0 SD526509020030 SD526509018030 SD514509271FV0 SD514509177FV0 SD514609061FV0 SD514509198FV0 SD514509266FV0 SD514509232FV0 SD514509233FV0 SD514609094FV0 SD514609073FV0 SD520809081FV0 SD514509182FV0 SD514509242FV0 SD514609086FV0 SD514509190FV0 SD514509212FV0 SD514609105FV0 SD514609023FV0 SD514609029FV0 SD514509173FV0 SD514609002FV0 SD514509204FV0 SD514509170FV0 SD514609107FV0 SD514509238FV0 SD514609019FV0 SD514509163FV0 SD536409020030
ClassificationClass II
Reason for RecallThe main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness.
Product Quantity186
Recall NumberZ-1941-2012

Class II Biologics Event

Event ID57770
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Dec-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710063798
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-2025-12

Class II Biologics Event

Event ID60076
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSurgical Tissue Network, Inc. dba TissueNet
CityOrlando
StateFL
CountryUS
Distribution PatternProducts were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.
 

Associated Products

Product DescriptionUltraC1 or C2, Cervical is labeled in part: "***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***UltraC1, Cervical***FD57506, 6mm Small label: "***ID:***UltraC1, Cervical***FD57507, 7mm Small label: "***ID:***UltraC1, Cervical***FD57508, 8mm Small label: "***ID:***UltraC2, Cervical***FD57607, 7mm
Code InfoProduct ID: FD57506, 6mm TN4211610002, TN4211610003, TN4211610004, TN4211610005, TN4211610006 TN4211610007, TN4211610008 Product ID: FD57507, 7mm TN4211610009, TN4211610010, TN421161001, TN4211610012, TN4211610013 TN4211610014 Product ID: FD57508, 8mm TN4211610015 Product ID: FD57607, 7mm TN4211610029, TN4211610030, TN4211610031, TN4211610032, TN4211610033
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity19 ea
Recall NumberB-1637-12
Product DescriptionCancellous Crushed is labeled in part: "***Tissue ID:***Description: Cancellous Crushed***Size 15cc-4mm-10mm***Product Code FD55315R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Cancellous Crushed***FD55315R EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610036, TN4211610037, TN4211610038, TN4211610039, TN4211610040, TN4211610041, TN4211610042, TN4211610043, TN4211610044, TN4211610045, TN4211610046, TN4211610047, TN4211610048, TN4211610049, TN4211610050
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity15 ea
Recall NumberB-1638-12
Product DescriptionCancellous Crushed is labeled in part: "***Tissue ID:***Description: Cancellous Crushed***Size 30cc-4mm-10mm***Product Code FD55330R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Cancellous Crushed***FD55330R EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610051, TN4211610052, TN4211610053, TN4211610054, TN4211610055, TN4211610056, TN4211610057, TN4211610058, TN4211610059, TN4211610060, TN4211610061, TN4211610062, TN4211610063, TN4211610064, TN4211610065
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity15 ea
Recall NumberB-1639-12
Product DescriptionUltrafill DBM Human is labeled in part: "***Tissue ID:***Description: Ultrafill DBM Human***Size 10cc***Product Code HM53010***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Ultrafill DBM Human***HM53010 EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610093, TN4211610094, TN4211610095, TN4211610096, TN4211610097
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity5 ea
Recall NumberB-1640-12
Product DescriptionUltrafill DBM Human is labeled in part: "***Tissue ID:***Description: Ultrafill DBM Human***Size 5cc***Product Code HM53005***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Ultrafill DBM Human***HM53005 EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610098, TN4211610099, TN4211610100, TN4211610101, TN4211610102, TN4211610103, TN4211610104, TN4211610105, TN4211610106, TN4211610107
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity10 ea
Recall NumberB-1641-12
Product DescriptionMineralized Bone is labeled in part: "***Processed by: TissueNet***7022 TPC Dr Ste 400***Orlando, FL 32822***Sterilized By: T106^(r) {SAL 10-6}***Tissue ID:***Description: Mineralized Bone***Size 5cc***Product Code MB50050***Expiration***Freeze Dried: Store at 10 C - 37 C***Donated Human Tissue Allograft***Single Patient Use Only***". Full Product Description: Mineralized Bone .125-.85mm 5cc
Code InfoProduct ID: TN4211610153, TN4211610154, TN4211610155, TN4211610156, TN4211610158, TN4211610159, TN4211610160, TN4211610161, TN4211610162, TN4211610163, TN4211610164, TN4211610165, TN4211610166, TN4211610167, TN4211610168, TN4211610169, TN4211610170, TN4211610171, TN4211610172, TN4211610173, TN4211610174, TN4211610175, TN4211610176, TN4211610177, TN4211610178, TN4211610179, TN4211610180
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity27 ea
Recall NumberB-1642-12
Product DescriptionFashioned UltraBTB is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraBTB***Size***Product Code FF99050***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraBTB***FF99050 EXP:***TissueNet 800-465-8800***" Full Product Description: Fashioned UltraBTB 10x10mm
Code InfoProduct ID: TN4211610073, TN4211610074, TN4211610075, TN4211610076
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity4 ea
Recall NumberB-1643-12
Product DescriptionFashioned UltraAchilles is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraAchilles***Size***Product Code FF94355***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraAchilles***FF94355 EXP:***TissueNet 800-465-8800***" Full Product Description: Fashioned Achilles 9mm
Code InfoProduct ID: TN4211610071, TN4211610072
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1644-12
Product DescriptionUltraTibialis (Anterior) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraTibialis (Anterior)***Size***Product Code FF84230***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraTibialis (Anterior) ***FF84230 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Tibialis Anterior
Code InfoProduct ID: TN4211610077, TN4211610078
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 ea
Recall NumberB-1645-12
Product DescriptionUltraP (Peroneus Longus) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraP (Peroneus Longus)***Size***Product Code FF93500***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraP (Peroneus Longus)***FF93500 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Peroneus Longus
Code InfoProduct ID: TN4211610079, TN4211610080
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 ea
Recall NumberB-1646-12
Product DescriptionUltra Tibialis (Posterior) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Tibialis (Posterior)***Size***Product Code FF84231***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Tibialis (Posterior)***FF84231 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Tibialis Posterior
Code InfoProduct ID: TN4211610081, TN4211610082
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 ea
Recall NumberB-1647-12
Product DescriptionUltra Semi-T (Semitendinosus) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Semi-T (Semitendinosus)***Size***Product Code FF83100***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Semi-T (Semitendinosus)***FF83100 EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610083, TN4211610084
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 ea
Recall NumberB-1648-12
Product DescriptionFascia Lata, Large is labeled in part: "***Tissue ID:***Description: Fascia Lata, Large***Size:***Product dimension***Product Code FD73520***EXPIRATION***Freeze Dried: Store at 10 c - 37 c***Sterilization Method: T106 Terminal Sterilization system***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***ID:***Fascia Lata, Large***FD73520 EXP:***TissueNet 800-465-8800***"
Code InfoProduct ID: TN4211610087, TN4211610088
ClassificationClass II
Reason for RecallHuman allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 ea
Recall NumberB-1649-12

Class II Biologics Event

Event ID60112
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAllograft Innovations, LLC
CityGainesville
StateFL
CountryUS
Distribution PatternAffected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.
 

Associated Products

Product DescriptionCancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .25-.5mm 15cc Cancellous Chips, Product Code 0306Al
Code InfoTissue ID/Donor ID# Al1000082005 and Al1000082006
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1625-12
Product DescriptionCancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .5-1mm 15cc, 30cc, and 1cc Cancellous Chips: Product Code 0308Al, .5-1mm 15cc Cancellous Chips Product Code 0309AI, .5-1mm 30cc Cancellous Chips Product Code 0326AI, .5-1mm 1cc Cancellous Chips
Code InfoTissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity15
Recall NumberB-1626-12
Product DescriptionCancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" 1-4mm 15cc, 30cc, and 60cc Cancellous Chips Product Code 0310Al, 1-4mm 15cc Cancellous Chips Product Code 0311AI, 1-4mm 30cc Cancellous Chips Product Code 0313AI, 1-4mm 60cc Cancellous Chips
Code InfoTissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity18
Recall NumberB-1627-12
Product DescriptionCancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" 4-10mm 15cc, 30cc, and 60cc Cancellous Chips: Product Code 0317AI, 4-10mm 15cc Cancellous Chips Product Code 0318Al, 4-10mm 30cc Cancellous Chips Product Code 0320Al. 4-10mm 60cc Cancellous Chips
Code InfoTissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity20
Recall NumberB-1628-12
Product DescriptionAchilles with Bone Block. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 0201Al
Code InfoDonor#/Tissue ID# A1000110005 and Al1000110006
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1629-12
Product DescriptionPatella Hemi. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 1901Al
Code InfoDonor#/Tissue ID# A1000110008
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-1630-12
Product DescriptionPatella Hemi Pre-Sized. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 1903Al
Code InfoDonor#/Tissue ID# A1000110009
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-1631-12
Product DescriptionTibialis Anterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2701Al
Code InfoDonor#/Tissue ID# A1000110010 and A1000110011
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1632-12
Product DescriptionTibialis Posterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013.
Code InfoDonor#/Tissue ID# A1000110012 and A1000110013
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1633-12
Product DescriptionPeroneous Longus "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2101Al
Code InfoDonor#/Tissue ID# A1000110014 and A1000110015
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-1634-12

Class II Devices Event

Event ID61555
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInvacare Corporation
CityElyria
StateOH
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.
 

Associated Products

Product DescriptionTDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.
Code InfoTDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, and FDX-MCG.
ClassificationClass II
Reason for RecallInvacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
Product Quantity665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified.
Recall NumberZ-1905-2012

Class II Devices Event

Event ID61749
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
 

Associated Products

Product DescriptionULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1906-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1907-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1908-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1909-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1910-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1911-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1912-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1913-2012
Product DescriptionULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Recall NumberZ-1914-2012
Product DescriptionLUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1915-2012
Product DescriptionLUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1916-2012
Product DescriptionLUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1917-2012
Product DescriptionLUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product QuantityEighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1918-2012
Product DescriptionLUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1919-2012
Product DescriptionLUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1920-2012
Product DescriptionLUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1921-2012
Product DescriptionLUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1922-2012
Product DescriptionLUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1923-2012
Product DescriptionLUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code InfoProduct code:152180010 and Lot numbers: A4VCY1000 and T76A61007.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Product Quantity85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Recall NumberZ-1924-2012

Class II Drugs Event

Event ID61871
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionMetoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
Code InfoLot #TE1Y261, Exp, 12/2013
ClassificationClass II
Reason for RecallTablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Product Quantity2,268 bottles
Recall NumberD-1409-2012

Class II Devices Event

Event ID61874
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
 

Associated Products

Product DescriptionDepuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code InfoAll lots
ClassificationClass II
Reason for RecallAdditional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity683 units
Recall NumberZ-1937-2012
Product DescriptionDepuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info All lots
ClassificationClass II
Reason for RecallAdditional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity704 units
Recall NumberZ-1938-2012
Product DescriptionDepuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code InfoAll lots
ClassificationClass II
Reason for RecallAdditional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity530 units
Recall NumberZ-1939-2012
Product DescriptionDepuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Code Info All lots
ClassificationClass II
Reason for RecallAdditional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product Quantity6979 units
Recall NumberZ-1940-2012

Class II Devices Event

Event ID61998
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMicrobiologics Inc
CitySaint Cloud
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.
 

Associated Products

Product DescriptionMicrobiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
Code Info0353 - 0355, 0357 - 0363
ClassificationClass II
Reason for RecallMicrobiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient.
Product Quantity13,720 slides (10 slides per box)
Recall NumberZ-1936-2012

Class II Food Event

Event ID62003
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmTree Top Inc - Selah Plant
CitySelah
StateWA
CountryUS
Distribution PatternShipped to accounts in VA and IA.
 

Associated Products

Product DescriptionPear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR JUICE CONCENTRATE "cRc-KOSHER"***52 GALLONS" and "TREE TOP***PEAR CONCENTRATE TYPE III***RESOURCE #: 4200815003***Selah, Wa. 98942***MADE IN USA***".
Code InfoLot numbers: "9321012001" and "9321012002"
ClassificationClass II
Reason for RecallThe product contains in excess of 23 ppb inorganic arsenic which exceeds the FDA published level of concern for a chronic exposure.
Product Quantity6708 gallons
Recall NumberF-1683-2012

Class II Food Event

Event ID62057
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUltradent Products, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternGlobal distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
 

Associated Products

Product DescriptionCinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
Code InfoLot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
ClassificationClass II
Reason for RecallUltradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Product Quantity17, 889 cartons
Recall NumberF-1708-2012
Product DescriptionXylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
Code InfoLot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
ClassificationClass II
Reason for RecallUltradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Product Quantity4,083 units
Recall NumberF-1709-2012
Product DescriptionSpearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
Code InfoLot numbers: B6Y7B.
ClassificationClass II
Reason for RecallUltradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.
Product Quantity668 units
Recall NumberF-1710-2012

Class II Food Event

Event ID62126
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPendleton Flour Mills, Llc
CityBlackfoot
StateID
CountryUS
Distribution PatternProduct was distributed to three consignees in CA, OR and UT.
 

Associated Products

Product DescriptionWheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344.
Code InfoDate of Manufacture: 2/16/12, 2/17/12, 2/18/12, 2/19/12, 2/20/12, 2/21/12.
ClassificationClass II
Reason for RecallWheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length.
Product Quantity16 totes (approximately 25,061 lbs)
Recall NumberF-1686-2012

Class II Devices Event

Event ID62137
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
 

Associated Products

Product DescriptionPathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Code InfoPart number 3564-1; all lots
ClassificationClass II
Reason for RecallComplaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events were filed as MDR reports since the location of the fi'agments from the broken set screw were unknown.
Product Quantity77 units
Recall NumberZ-1933-2012

Class II Devices Event

Event ID62240
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAesculap Implant Systems LLC
CityCenter Valley
StatePA
CountryUS
Distribution PatternNationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
 

Associated Products

Product DescriptionS4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Code InfoAll distributed lot numbers and serial numbers
ClassificationClass II
Reason for RecallAesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Product Quantity15
Recall NumberZ-1934-2012

Class II Devices Event

Event ID62270
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.
 

Associated Products

Product DescriptionPhilips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Code Info Software R2.1 L 1 SP2
ClassificationClass II
Reason for RecallXcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Product Quantity226 units
Recall NumberZ-1942-2012

Class II Devices Event

Event ID62283
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmThayer Medical Corporation
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, KY and Europe.
 

Associated Products

Product DescriptionAirLife® MiniSpacer® MDI Dispenser Adapter. Dual-Spray MiniSpacer® Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer® is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile.
Code InfoPRODUCT CODES Affected Lot Number(s) (US): 120320, 120410 Affected Lot Number (EU only): 120405 Expiration Date: Not Applicable Serial Number: Not Applicable UPC Code (individual device): (01) 00885403167839 UPC Code (case): (01) 50885403167834 Brand Name: AirLife® MiniSpacer® MDI Dispenser Adapter Description: 15 mm O.D. / I.D. connections Catalogue Number: 002092 US Product Code: CAF FDA 510(k) Number: K955805
ClassificationClass II
Reason for RecallInternal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.
Product Quantity19340
Recall NumberZ-1927-2012

Class II Food Event

Event ID62309
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNewly Weds Foods Inc
CityChicago
StateIL
CountryUS
Distribution PatternCalifornia, Florida, Indiana, Maryland, Ohio, Tennessee and Texas
 

Associated Products

Product DescriptionTurkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
Code Infoproduct G00988, lot numbers YE303312 and MT618006
ClassificationClass II
Reason for RecallThe products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella.
Product Quantity4,450 lbs.
Recall NumberF-1684-2012
Product DescriptionFirewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189
Code Infoproduct G51189, lot numbers MT618160, MT618809, MT620049 and MT621951
ClassificationClass II
Reason for RecallThe products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella.
Product Quantity6,600 lbs
Recall NumberF-1685-2012

Class II Drugs Event

Event ID62350
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling Firmsanofi-aventis US, Inc.
CityBridgewater
StateNJ
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionEloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Code InfoLot number and expiration dates Eloxatin® (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CA02B 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial AE27 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial BL18B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CB13B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CD65B 01/ 2014 Eloxatin® (OXALIplatin injection) 50mg vial CE39B 01/ 2014
ClassificationClass II
Reason for RecallCGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Product Quantity196,355 vials
Recall NumberD-1407-2012
Product DescriptionEloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Code InfoLot number and expiration dates Eloxatin® (OXALIplatin injection) 100mg vial AD21 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AD22 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE24 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE25 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF55 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE26 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF03 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF04 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF21 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BL19B 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB11B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB102B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB12B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CA01B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH07 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH08 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH09 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CC109B 01/ 2014
ClassificationClass II
Reason for RecallCGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Product Quantity387,738 vials
Recall NumberD-1408-2012

Class II Food Event

Event ID62385
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSeoul Shik Poom, Inc.
CityEnglewood
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionFrozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Code InfoAll Korean oysters that has the Choripdong Label on it.
ClassificationClass II
Reason for RecallKorean Certified Shippers delisted from ICSSL.
Product Quantity412 cases
Recall NumberF-1713-2012
Product DescriptionFrozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Code InfoFrozen salted clam, 12/210g; Item # MB3023.
ClassificationClass II
Reason for RecallKorean Certified Shippers delisted from ICSSL.
Product Quantity3 cases
Recall NumberF-1714-2012

Class II Food Event

Event ID62388
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHealthy Choice/Island Blends, Inc. (dba Juice Connection)
CityLos Angeles
StateCA
CountryUS
Distribution PatternDistribution within CA.
 

Associated Products

Product DescriptionCarrot juice. Labeling reads in part:"***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***".
Code InfoUPC Code 7 63213 00130 0
ClassificationClass II
Reason for RecallThe firm's carrot juice has the potential to be contaminated with Clostridium botulinum.
Product Quantity118 gallons
Recall NumberF-1707-2012

Class II Food Event

Event ID62417
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSR Rosati, Inc
CityClifton Heights
StatePA
CountryUS
Distribution PatternProduct was distributed within the United States to AL, DE, GA, MA, MI, NC, and VA. Approximately 75% is still within the firm's control.
 

Associated Products

Product DescriptionRosati Cry Baby Sour Watermelon water ice, 6 fl oz
Code InfoLot N08670
ClassificationClass II
Reason for RecallProduct label does not declare FD&C Yellow #5
Product Quantity4,608 cases of 12/6 oz cups
Recall NumberF-1712-2012

Class II Food Event

Event ID62424
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCedars Bakery
CityDearborn
StateMI
CountryUS
Distribution Patternretail bakery and restaurants in Wayne, Oakland and Macomb counties of Michigan
 

Associated Products

Product DescriptionCedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs)
Code Infonone
ClassificationClass II
Reason for RecallCedar's Bakery White Pita Bread, does not list the source of the flour ingredient as wheat, an allergen.
Product Quantity~ 700 bags
Recall NumberF-1711-2012

Class II Devices Event

Event ID62447
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreiner Bio-One North America, Inc.
CityMonroe
StateNC
CountryUS
Distribution PatternNationwide Distribution including IL, MS, OH, PA, TN and VA.
 

Associated Products

Product DescriptionVacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Code InfoItem #450239, Lot #G110601I and Item #450235, Lot #G110302J.
ClassificationClass II
Reason for Recall: The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Product Quantity19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Recall NumberZ-1935-2012

Class II Food Event

Event ID62458
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSeoul Trading Inc.
CityAuburn
StateWA
CountryUS
Distribution PatternProducts were distributed to Oregon and Washington
 

Associated Products

Product DescriptionCho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb.
Code Infounknown
ClassificationClass II
Reason for RecallKorean oysters have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity1)150 cases/; 2) 180 cases; 3) 90 cases; 4) 100 cases; 5) 60 cases
Recall NumberF-1717-2012
Product DescriptionNol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb.
Code Infoexpiration date: 04/17/2013
ClassificationClass II
Reason for Recallproduct containing mussel has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity20 cases/8 pkg/1.21 lb
Recall NumberF-1718-2012
Product DescriptionNa-Rae NR, Salted & Fermented Oyster, item no. MA1159, net wt. 44 lb per case. Cho-Rip-Dong Salted & Fermented Oyster, item no. MB3025, net wt. 7.4 oz per bag.
Code Infoexpiration date: 09/23/2013
ClassificationClass II
Reason for Recallproduct has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity33 cases/44 lbs and 3 cases/12 pkg/7.4 oz.
Recall NumberF-1719-2012

Class III Biologics Event

Event ID57375
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Sep-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA, Austria
 

Associated Products

Product DescriptionRecovered Plasma
Code InfoW128710068173
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose arm inspection was not documented, were distributed.
Product Quantity1 unit
Recall NumberB-2026-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710068173
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose arm inspection was not documented, were distributed.
Product Quantity1 unit
Recall NumberB-2027-12

Class III Devices Event

Event ID61525
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp. d.b.a. Integra Pain Management
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNationwide Distribution including MA
 

Associated Products

Product DescriptionSingle Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
Code InfoLot W1112119
ClassificationClass III
Reason for RecallIntegra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Product Quantity4 cases x 10 units per case
Recall NumberZ-1943-2012

Class III Drugs Event

Event ID61872
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
CityFort Washington
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionImodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Code InfoLot #CMF023, Expiration 07/13.
ClassificationClass III
Reason for RecallDefective Container; damaged blister units
Product Quantity53,892 packages
Recall NumberD-1404-2012

Class III Food Event

Event ID61909
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Dannon Company Inc
CityMinster
StateOH
CountryUS
Distribution PatternUS distribution only: Illinois, Wisconsin and Minnesota.
 

Associated Products

Product DescriptionDannon Fruit on the Bottom, Raspberry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
Code InfoLot code 63210
ClassificationClass III
Reason for RecallRoutine testing by the firm showed the presence of Coliforms in absence of E. coli.
Product Quantity1,350 cases for all products in Recall Event
Recall NumberF-1638-2012
Product DescriptionDannon Fruit on the Bottom, Mixed Berry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
Code InfoLot code 63215
ClassificationClass III
Reason for RecallRoutine testing by the firm showed the presence of Coliforms in absence of E. coli.
Product Quantity1,350 cases for all products in Recall Event
Recall NumberF-1639-2012

Class III Drugs Event

Event ID61934
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRanbaxy Inc.
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBalnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Code InfoLot #: RB81031, Exp 01/13
ClassificationClass III
Reason for RecallSubpotent (single Ingredient Drug): out of specification result for coal tar content assay.
Product Quantity2544 bottles
Recall NumberD-1405-2012

Class III Biologics Event

Event ID62079
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160060733; 2160062847; 2160065473;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1809-12

Class III Biologics Event

Event ID62080
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160069344;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1810-12

Class III Biologics Event

Event ID62081
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160072103; 2160076211;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1811-12

Class III Biologics Event

Event ID62082
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160082721; 2160071425; 2160073352; 2160076030;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1812-12

Class III Biologics Event

Event ID62083
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160067524; 2160078501; 2160079479; 2160081725; 2160084136; 2160059822; 2160064134; 2160065636;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity8
Recall NumberB-1813-12

Class III Biologics Event

Event ID62084
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160060189; 2160061770; 2160062511;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1814-12

Class III Biologics Event

Event ID62085
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077043; 2160077514; 2160062372; 2160064154; 2160074491;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity5
Recall NumberB-1815-12

Class III Biologics Event

Event ID62086
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160064423; 2160069367; 2160069826; 2160079559;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1816-12

Class III Biologics Event

Event ID62087
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160061447; 2160071525; 2160082452;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1817-12

Class III Biologics Event

Event ID62088
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077149;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1818-12

Class III Biologics Event

Event ID62089
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077746; 2160082719;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1819-12

Class III Biologics Event

Event ID62090
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160081717; 2160083398;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1820-12

Class III Biologics Event

Event ID62091
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160078530; 2160060203; 2160065145; 2160071517; 2160078190;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity5
Recall NumberB-1821-12

Class III Biologics Event

Event ID62092
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160074168; 2160078344;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1822-12

Class III Biologics Event

Event ID62093
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160059356; 2160059962;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1823-12

Class III Biologics Event

Event ID62094
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160068577;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1824-12

Class III Biologics Event

Event ID62095
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160066843;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1825-12

Class III Biologics Event

Event ID62184
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160062308; 2160068966;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1843-12

Class III Biologics Event

Event ID62185
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160081036;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1883-12

Class III Biologics Event

Event ID62186
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160063498;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1884-12

Class III Biologics Event

Event ID62187
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160059814; 2160067375;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1885-12

Class III Biologics Event

Event ID62188
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160058180; 2160062907;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1886-12

Class III Biologics Event

Event ID62189
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160073430;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1887-12

Class III Biologics Event

Event ID62190
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160062987; 2160074078;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1888-12

Class III Biologics Event

Event ID62191
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160063042; 2160063876;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1889-12

Class III Biologics Event

Event ID62192
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160078137;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1890-12

Class III Biologics Event

Event ID62193
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160064991; 2160069116; 2160070885;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1891-12

Class III Biologics Event

Event ID62194
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160058966; 2160059586;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1892-12

Class III Biologics Event

Event ID62196
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160079822; 2160080589;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1894-12

Class III Biologics Event

Event ID62197
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160063733; 2160065091; 2160066720; 2160068524; 2160069915; 2160083083;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity6
Recall NumberB-1895-12

Class III Biologics Event

Event ID62198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160069116; 2160070885; 2160064991;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1896-12

Class III Biologics Event

Event ID62200
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160078367; 2160073485; 2160069938; 2160067984; 2160081122; 2160082792; 2160069055;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity7
Recall NumberB-1898-12

Class III Biologics Event

Event ID62201
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160072827;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1899-12

Class III Biologics Event

Event ID62202
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160068777; 2160070279; 2160079153;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1900-12

Class III Biologics Event

Event ID62203
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160059954; 2160073116;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1901-12

Class III Biologics Event

Event ID62204
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160079113; 2160079445;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1902-12

Class III Biologics Event

Event ID62205
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160057765;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1903-12

Class III Biologics Event

Event ID62206
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160060981;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1904-12

Class III Biologics Event

Event ID62207
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160076135; 2160076922; 2160077844;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-1905-12

Class III Biologics Event

Event ID62208
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160081453;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1906-12

Class III Biologics Event

Event ID62209
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160064006; 2160075573; 2160076829; 2160061898;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1907-12

Class III Biologics Event

Event ID62210
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160082410;
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1908-12

Class III Food Event

Event ID62289
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAldi Inc
CityBatavia
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionNorthern Catch Harvest of the Sea Fancy Whole Oysters and SeaNet Fancy Whole Oysters; Net Wt. 8 oz (227g) cans, 12 cans per carton; Distributed by Aldi Inc., Batavia, IL 60510-1477; Product of Korea; UPC 0 41498 11984 3
Code InfoAll lots of both brand names sold between February 20, 2009 and May 29, 2012
ClassificationClass III
Reason for RecallThe product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity116,533 cartons
Recall NumberF-1724-2012

Class III Drugs Event

Event ID62383
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWatson Laboratories Inc
CityCorona
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLoxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Code InfoLot 108094A
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity8254 bottles
Recall NumberD-1399-2012
Product DescriptionLoxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Code InfoLot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity106,323 bottles
Recall NumberD-1400-2012
Product DescriptionLoxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
Code InfoLot #s: 101696A, 110829A, 123685A, 123687A
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity21,572 bottles
Recall NumberD-1401-2012
Product DescriptionLoxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Code InfoLot #s: 104432A, 104433A, 121344A, 127024A, 144290A
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity18,902 bottles
Recall NumberD-1402-2012
Product DescriptionLoxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Code InfoLot # 22478A
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Product Quantity7,262 bottles
Recall NumberD-1403-2012

Class III Food Event

Event ID62438
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMitsui Foods Inc
CityNorwood
StateNJ
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionWhole Oysters: 1) Empress Whole Oysters, NET WT 8 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC 7360000719. 2) Premium Quality Private Selection Whole Oysters, NET WT 8 OZ. Distributed By Inter-American Products, Inc. Cincinnati, OH 45202. Product of Korea, UPC 111081484.
Code InfoLot Numbers: 405046-006, 405046-007, 406639-005, 406670-004, 406716-001, 406781-004, 407995-001, 407995-003, 408080-001, 408080-002, 406443-001, 406639-002, 406639-004, 406777-001, 406780-001, 406780-003, 406781-003, 406639-001, 406639-003, 406639-006, 406777-002, 406670-002, and 407995-002.
ClassificationClass III
Reason for RecallAs of May 1, Korean shellfish imports have been blocked by the United States because Korean waters may have been polluted. FDA said that all Korean certified shippers of molluscan shellfish were removed from the Interstate Certified Shellfish Shippers List. Therefore, FDA said that food distributors, retailers and food service operators should "remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them." Out of an abundance of caution, Mitsui Foods is requesting the return of all Korean oyster product that you may have on hand.
Product Quantity20,074 cases Empress products: 77,437 Private Select products
Recall NumberF-1715-2012
Product DescriptionSmoked Oysters: 1) Empress Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC7360000713. 2) Premium Quality Private Selection Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea. Farm Raised, UPC 111081484.
Code InfoLot Numbers: 405046-006, 405046-007, 406639-005, 406670-004, 406716-001, 406781-004, 407995-001, 407995-003, 408080-001, 408080-002, 406443-001, 406639-002, 406639-004, 406777-001, 406780-001, 406780-003, 406781-003, 406639-001, 406639-003, 406639-006, 406777-002, 406670-002, and 407995-002.
ClassificationClass III
Reason for RecallAs of May 1, Korean shellfish imports have been blocked by the United States because Korean waters may have been polluted. FDA said that all Korean certified shippers of molluscan shellfish were removed from the Interstate Certified Shellfish Shippers List. Therefore, FDA said that food distributors, retailers and food service operators should "remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them." Out of an abundance of caution, Mitsui Foods is requesting the return of all Korean oyster product that you may have on hand.
Product QuantityPrivate Select brand products: 77,437 cases; Empress 20,074
Recall NumberF-1716-2012

Class III Drugs Event

Event ID62442
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHealth Plus Incorporated
CityChino
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSuper Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Code InfoLot number 120502276, Expiration date 05/2015, UPC Code 08807/11/0 -- revision number 08807/11/0. Lot number 120201286, Expiration date 03/2015, UPC Code 08807/11/0.
ClassificationClass III
Reason for RecallLabeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Product Quantity24,423 bottles
Recall NumberD-1406-2012

Mixed Classification Biologics Event

Event ID62195
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160082085; 2160070284; 2160069890; 2160073365;
ClassificationClass II
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1893-12

Mixed Classification Food Event

Event ID62336
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMexicantown Wholesale
CityDetroit
StateMI
CountryUS
Distribution PatternCANADA ONLY
 

Associated Products

Product DescriptionMUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz
Code InfoUPC: 9564000029; and item #003 All products distributed on 5/15/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. this product was recalled due to undeclared soy (soy four and soybean oil) and milk (nonfat milk).
Product Quantity50 products (Canadian distribution only)
Recall NumberF-1689-2012
Product DescriptionMUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
Code InfoAll products distributed on 5/15/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil).
Product Quantity80 products (Canadian distribution only)
Recall NumberF-1690-2012
Product DescriptionMuffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2) MUFFIN W/PECANS MEXICAN SWEET BREAD IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz, UPC 9564000029; 3) MUFFINS W/PECANS (MEXICAN SWEET BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4.0oz
Code Info1) All products distributed on 5/15/2012; 2) all products distributed on 5/11/12; 3) all products distributed on 5/9/12 and 5/16/12
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy bean oil and soy flour).
Product Quantity1) 50 products; 2) 200 3) 100 (Canadian distributed only)
Recall NumberF-1691-2012
Product DescriptionPOLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
Code InfoUPC: 9564000016 All products distributed on 5/15/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5, yellow #6 and red #40.
Product Quantity40 products (Canadian distribution only)
Recall NumberF-1692-2012
Product DescriptionCONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4/4.0oz;, UPC 0895640000; 3) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4/4.0OZ, UPC 0895640000
Code Info1) All products distributed on 5/15/2012. 2) All products distributed on 5/9/2012 and 5/16/12 3) All products distributed 5/9-16/2012
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6.
Product Quantity1) 50 products; 2) 40; 3) 96(Canadian distribution only)
Recall NumberF-1693-2012
Product DescriptionCUERNOS: 1) CUERNOS/CROISSANT (MEXICAN SWEET BREAD/Pain sucre) IMPORTED BY MAX PRODUCTS LEAMINGTON 519-325-1176, 4 oz., UPC 9564000035; 2) CUERNOS PLAIN (MEXICAN SWEET BREAD/PAIN SUCRE) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4.0OZ, UPC: 9564000035
Code Info1) All products distributed on 5/11/2012. 2) All products disbributed on 5/9/12 and 5/16/12.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6.
Product Quantity1) 200 products (Canada distributed only); 2) 12
Recall NumberF-1694-2012
Product DescriptionTACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
Code InfoUPC: 9564000010; and item #002 All products distributed 5/15/2012.
ClassificationClass III
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared SULFITES.
Product Quantity7 products (Canada distribution only)
Recall NumberF-1695-2012
Product DescriptionMAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Code InfoUPC: 9564000019; and item #002 All products distributed on 5/15/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity150 products (Canada distribution only)
Recall NumberF-1696-2012
Product DescriptionTORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Code InfoUPC: 9564000053; and item #002 All products distributed on 5/15/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (liquid milk added), FD&C yellow #6, and wheat (flour).
Product Quantity10 products (Canada distribution only)
Recall NumberF-1697-2012
Product DescriptionMUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
Code InfoUPC: 9564000029 All products distributed on 5/10/12 and 5/17/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), Soy (soybean oil and soy flour), FD&C yellow #6, and wheat (flour).
Product Quantity6 products (Canada distribution only)
Recall NumberF-1698-2012
Product DescriptionMUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12
Code InfoUPC: 9564000029; and item #002 All products distributed on 5/10/12 and 5/17/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared milk (nonfat milk), soy (soybean oil and soy flour), and wheat (flour).
Product Quantity6 products(Canada distribution only)
Recall NumberF-1699-2012
Product DescriptionTORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
Code InfoUPC: 9564000053; and item #002 All products distributed on 5/10/12 and 5/17/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity4 products (Canada distribution only)
Recall NumberF-1700-2012
Product Description1) EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12, UPC: 9564000009 2) EMPANADAS DE PINA (MEXICAN SWEET BREAD/pain sucre) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 3.4oz
Code Info1) All products distributed on 5/10/12 and 5/17/2012. 2) All products distributed on 5/9/12 and 5/16/12.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6.
Product Quantity1) 10 products; 2) 100 products (Canada distribution only)
Recall NumberF-1701-2012
Product DescriptionPOLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Code InfoUPC: 9564000009 All products distributed on 5/10/12 and 5/17/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6 AND RED #40.
Product Quantity10 products (Canada distribution only)
Recall NumberF-1702-2012
Product DescriptionEMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Code InfoUPC: 9564000009 All products distributed on 5/10/2012 and 5/17/2012.
ClassificationClass III
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared RED#40.
Product Quantity8 products (Canada distribution only)
Recall NumberF-1703-2012
Product DescriptionCONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
Code InfoUPC: 0895640000 All products distributed on 5/11/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5 and yellow #6.
Product Quantity50 products (Canada distribution only)
Recall NumberF-1704-2012
Product DescriptionEMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz
Code InfoUPC: 9564000009 All products distributed on 5/11/2012.
ClassificationClass II
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6 and yellow #5.
Product Quantity100 products (Canada distribution only)
Recall NumberF-1705-2012
Product DescriptionMUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
Code InfoUPC: 9564000029 All products distributed 5/10-17/2012.
ClassificationClass I
Reason for RecallThe firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared wheat (flour), milk, and soy (soybean oil and soy flour).
Product Quantity126 products (Canada distribution only)
Recall NumberF-1706-2012
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