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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced W045007902862 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced 9049505 Class II Blood products, collected from a donor with a history of living in an HIV-O risk area, were distributed. Belle Bonfils Memorial Blood Center
Biologics Blood and Blood Products for Reprocessing 9049505 Class II Blood products, collected from a donor with a history of living in an HIV-O risk area, were distributed. Belle Bonfils Memorial Blood Center
Biologics Platelets Pheresis Leukocytes Reduced 09GZ09998; 09GZ10010; 09GZ10011 Class II Blood products, which were labeled as leukoreduced, but did not have leukoreduction testing completed were distributed. American National Red Cross (The)
Biologics Red Blood Cells 004LE80082, 004LE80083, 004LE80084, 004LE80086, 004LE80087, 004LE80095, 004LE80097, 004LE80098, 004LE80099, 004LE80100 Class II Blood products, collected using equipment that was not validated, were distributed. ARC Blood Services, New England Region
Biologics Fresh Frozen Plasma 004LE80082, 004LE80083, 004LE80087, 004LE80099 Class II Blood products, collected using equipment that was not validated, were distributed. ARC Blood Services, New England Region
Biologics Source Plasma 09DIAJ5514;09DIAK4140;09DIAK3063;09DIAJ8774;09DIAJ7748;09DIAJ4642;09DIAJ2790;09DIAI8746;09DIAI7925;09DIAI6004;09DIAI4991;09DIAI3181;09DIAI2161;09DIAI0015;09DIAH8793;09DIAH7191;09DIAH5965;09DIAJ1752 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. BioLife Plasma Services L.P.
Devices Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. SC609PS 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 Class II The 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. Pride Mobility Products Corp
Biologics Recovered Plasma W128710068173 Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128710068173 Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128710063798 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Delta Blood Bank
Biologics UltraC1 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 Product 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 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Cancellous 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***" Product ID: TN4211610036, TN4211610037, TN4211610038, TN4211610039, TN4211610040, TN4211610041, TN4211610042, TN4211610043, TN4211610044, TN4211610045, TN4211610046, TN4211610047, TN4211610048, TN4211610049, TN4211610050 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Cancellous 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***" Product ID: TN4211610051, TN4211610052, TN4211610053, TN4211610054, TN4211610055, TN4211610056, TN4211610057, TN4211610058, TN4211610059, TN4211610060, TN4211610061, TN4211610062, TN4211610063, TN4211610064, TN4211610065 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Ultrafill 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***" Product ID: TN4211610093, TN4211610094, TN4211610095, TN4211610096, TN4211610097 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Ultrafill 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***" Product ID: TN4211610098, TN4211610099, TN4211610100, TN4211610101, TN4211610102, TN4211610103, TN4211610104, TN4211610105, TN4211610106, TN4211610107 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Mineralized 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 Product 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 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Fashioned 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 Product ID: TN4211610073, TN4211610074, TN4211610075, TN4211610076 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Fashioned 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 Product ID: TN4211610071, TN4211610072 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics UltraTibialis (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 Product ID: TN4211610077, TN4211610078 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics UltraP (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 Product ID: TN4211610079, TN4211610080 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Ultra 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 Product ID: TN4211610081, TN4211610082 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Ultra 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***" Product ID: TN4211610083, TN4211610084 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Fascia 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***" Product ID: TN4211610087, TN4211610088 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. Surgical Tissue Network, Inc. dba TissueNet
Biologics Cancellous 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 Tissue ID/Donor ID# Al1000082005 and Al1000082006 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous 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 Tissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous 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 Tissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous 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 Tissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Achilles 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 Donor#/Tissue ID# A1000110005 and Al1000110006 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Patella 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 Donor#/Tissue ID# A1000110008 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Patella 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 Donor#/Tissue ID# A1000110009 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Tibialis 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 Donor#/Tissue ID# A1000110010 and A1000110011 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Tibialis 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. Donor#/Tissue ID# A1000110012 and A1000110013 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Peroneous 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 Donor#/Tissue ID# A1000110014 and A1000110015 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Devices Single 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. Lot W1112119 Class III Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. Integra LifeSciences Corp. d.b.a. Integra Pain Management
Devices TDX 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. 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, and FDX-MCG. Class II Invacare 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. Invacare Corporation
Devices ULTIMA*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. Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21 Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12 Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices ULTIMA*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. Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000. Class II DePuy 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. DePuy Orthopaedics, Inc.
Devices LUSTER 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. Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007. Class II DePuy 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. DePuy Orthopaedics, Inc.
Drugs Metoprolol 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 Lot #TE1Y261, Exp, 12/2013 Class II Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight) Teva Pharmaceuticals USA, Inc.
Drugs Imodium 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 Lot #CMF023, Expiration 07/13. Class III Defective Container; damaged blister units Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Devices Depuy 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. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices Depuy 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. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices Depuy 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. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices Depuy 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. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles DePuy Mitek, Inc., a Johnson & Johnson Co.
Food Dannon Fruit on the Bottom, Raspberry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling. Lot code 63210 Class III Routine testing by the firm showed the presence of Coliforms in absence of E. coli. The Dannon Company Inc
Food Dannon Fruit on the Bottom, Mixed Berry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling. Lot code 63215 Class III Routine testing by the firm showed the presence of Coliforms in absence of E. coli. The Dannon Company Inc
Drugs Balnetar 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 Lot #: RB81031, Exp 01/13 Class III Subpotent (single Ingredient Drug): out of specification result for coal tar content assay. Ranbaxy Inc.
Devices AirLife 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. product 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. Class I The 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. Carefusion 2200 Inc
Devices AirLife 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. product 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. Class I The 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. Carefusion 2200 Inc
Devices AirLife 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. product 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. Class I The 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. Carefusion 2200 Inc
Devices Microbiologics 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. 0353 - 0355, 0357 - 0363 Class II Microbiologics 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. Microbiologics Inc
Food Pear 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***". Lot numbers: "9321012001" and "9321012002" Class II The product contains in excess of 23 ppb inorganic arsenic which exceeds the FDA published level of concern for a chronic exposure. Tree Top Inc - Selah Plant
Food Cinnamon 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. Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN. Class II Ultradent 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. Ultradent Products, Inc.
Food Xylishield 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. Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9. Class II Ultradent 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. Ultradent Products, Inc.
Food Spearmint 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. Lot numbers: B6Y7B. Class II Ultradent 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. Ultradent Products, Inc.
Biologics Source Plasma 2160060733; 2160062847; 2160065473; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069344; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160072103; 2160076211; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082721; 2160071425; 2160073352; 2160076030; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160067524; 2160078501; 2160079479; 2160081725; 2160084136; 2160059822; 2160064134; 2160065636; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160060189; 2160061770; 2160062511; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160077043; 2160077514; 2160062372; 2160064154; 2160074491; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160064423; 2160069367; 2160069826; 2160079559; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160061447; 2160071525; 2160082452; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160077149; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160077746; 2160082719; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081717; 2160083398; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160078530; 2160060203; 2160065145; 2160071517; 2160078190; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160074168; 2160078344; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059356; 2160059962; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160068577; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066843; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Food Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344. Date of Manufacture: 2/16/12, 2/17/12, 2/18/12, 2/19/12, 2/20/12, 2/21/12. Class II Wheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length. Pendleton Flour Mills, Llc
Devices PathFinder 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. Part number 3564-1; all lots Class II Complaints 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. Zimmer, Inc.
Biologics Source Plasma 2160062308; 2160068966; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081036; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160063498; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059814; 2160067375; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058180; 2160062907; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160073430; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160062987; 2160074078; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063042; 2160063876; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160078137; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064991; 2160069116; 2160070885; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058966; 2160059586; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082085; 2160070284; 2160069890; 2160073365; Class II Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160079822; 2160080589; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063733; 2160065091; 2160066720; 2160068524; 2160069915; 2160083083; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069116; 2160070885; 2160064991; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160078367; 2160073485; 2160069938; 2160067984; 2160081122; 2160082792; 2160069055; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160072827; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160068777; 2160070279; 2160079153; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059954; 2160073116; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160079113; 2160079445; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160057765; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060981; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160076135; 2160076922; 2160077844; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081453; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064006; 2160075573; 2160076829; 2160061898; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082410; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Devices S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery. All distributed lot numbers and serial numbers Class II Aesculap 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. Aesculap Implant Systems LLC
Devices Philips 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. Software R2.1 L 1 SP2 Class II Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Philips Healthcare Inc.
Devices AirLife® 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. PRODUCT 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 Class II Internal 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. Thayer Medical Corporation
Food Northern 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 All lots of both brand names sold between February 20, 2009 and May 29, 2012 Class III The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Aldi Inc
Food Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988 product G00988, lot numbers YE303312 and MT618006 Class II The products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella. Newly Weds Foods Inc
Food Firewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189 product G51189, lot numbers MT618160, MT618809, MT620049 and MT621951 Class II The products were manufactured using a roast meat flavor yeast extract recalled by DSM Nutritional Products, Llc. because it is contaminated with Salmonella. Newly Weds Foods Inc
Food MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz UPC: 9564000029; and item #003 All products distributed on 5/15/2012. Class I The firm recalled 26 products for undeclared allergens. this product was recalled due to undeclared soy (soy four and soybean oil) and milk (nonfat milk). Mexicantown Wholesale
Food MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001 All products distributed on 5/15/2012. Class I The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy flour and soybean oil). Mexicantown Wholesale
Food Muffins 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 1) 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 Class I The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared soy (soy bean oil and soy flour). Mexicantown Wholesale
Food POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz UPC: 9564000016 All products distributed on 5/15/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5, yellow #6 and red #40. Mexicantown Wholesale
Food CONCHAS: 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 1) 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 Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6. Mexicantown Wholesale
Food CUERNOS: 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 1) All products distributed on 5/11/2012. 2) All products disbributed on 5/9/12 and 5/16/12. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6. Mexicantown Wholesale
Food TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz UPC: 9564000010; and item #002 All products distributed 5/15/2012. Class III The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared SULFITES. Mexicantown Wholesale
Food MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz UPC: 9564000019; and item #002 All products distributed on 5/15/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6. Mexicantown Wholesale
Food TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz UPC: 9564000053; and item #002 All products distributed on 5/15/2012. Class I The 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). Mexicantown Wholesale
Food MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12 UPC: 9564000029 All products distributed on 5/10/12 and 5/17/2012. Class I The 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). Mexicantown Wholesale
Food MUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12 UPC: 9564000029; and item #002 All products distributed on 5/10/12 and 5/17/2012. Class I The 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). Mexicantown Wholesale
Food TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz UPC: 9564000053; and item #002 All products distributed on 5/10/12 and 5/17/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6. Mexicantown Wholesale
Food 1) 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 1) All products distributed on 5/10/12 and 5/17/2012. 2) All products distributed on 5/9/12 and 5/16/12. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6. Mexicantown Wholesale
Food POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12 UPC: 9564000009 All products distributed on 5/10/12 and 5/17/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared YELLOW #6 AND RED #40. Mexicantown Wholesale
Food EMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12 UPC: 9564000009 All products distributed on 5/10/2012 and 5/17/2012. Class III The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared RED#40. Mexicantown Wholesale
Food CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz UPC: 0895640000 All products distributed on 5/11/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #5 and yellow #6. Mexicantown Wholesale
Food EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz UPC: 9564000009 All products distributed on 5/11/2012. Class II The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared yellow #6 and yellow #5. Mexicantown Wholesale
Food MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz UPC: 9564000029 All products distributed 5/10-17/2012. Class I The firm recalled 26 products for undeclared allergens. This product was recalled due to undeclared wheat (flour), milk, and soy (soybean oil and soy flour). Mexicantown Wholesale
Food Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374 Product sold in retail bakery prior to 6/15/12 Class I Undeclared egg Hannaford Bros.
Drugs Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 Lot 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 Class II CGMP 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. sanofi-aventis US, Inc.
Drugs Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20 Lot 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 Class II CGMP 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. sanofi-aventis US, Inc.
Food Crispy 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 UPC 627265002176 with best by dates up to March 27, 2013 Class I Products may contain undeclared milk. Deep Foods Inc
Food Crispy 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. UPC 627265005214 with best by dates up to March 27, 2013 Class I Products may contain undeclared milk. Deep Foods Inc
Food Crispy 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 UPC 6 27265 005221 6; All codes, best before March 29, 2013. Class I Products may contain undeclared milk. Deep Foods Inc
Food Crispy 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. UPC 6 27265 00161 2; All codes, best before March 29, 2013. Class I Products may contain undeclared milkand almonds. Deep Foods Inc
Drugs Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. Lot 108094A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Watson Laboratories Inc
Drugs Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A. Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Watson Laboratories Inc
Drugs Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 Lot #s: 101696A, 110829A, 123685A, 123687A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Watson Laboratories Inc
Drugs Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Watson Laboratories Inc
Drugs Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 Lot # 22478A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Watson Laboratories Inc
Food Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea. All Korean oysters that has the Choripdong Label on it. Class II Korean Certified Shippers delisted from ICSSL. Seoul Shik Poom, Inc.
Food Frozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea. Frozen salted clam, 12/210g; Item # MB3023. Class II Korean Certified Shippers delisted from ICSSL. Seoul Shik Poom, Inc.
Food Carrot juice. Labeling reads in part:"***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***". UPC Code 7 63213 00130 0 Class II The firm's carrot juice has the potential to be contaminated with Clostridium botulinum. Healthy Choice/Island Blends, Inc. (dba Juice Connection)
Food Rosati Cry Baby Sour Watermelon water ice, 6 fl oz Lot N08670 Class II Product label does not declare FD&C Yellow #5 SR Rosati, Inc
Food Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs) none Class II Cedar's Bakery White Pita Bread, does not list the source of the flour ingredient as wheat, an allergen. Cedars Bakery
Food Whole 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. Lot 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. Class III As 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. Mitsui Foods Inc
Food Smoked 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. Lot 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. Class III As 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. Mitsui Foods Inc
Drugs Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA. Lot 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. Class III Labeling: 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. Health Plus Incorporated
Devices Vacuette 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. Item #450239, Lot #G110601I and Item #450235, Lot #G110302J. Class II : 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. Greiner Bio-One North America, Inc.
Food Cho-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. unknown Class II Korean 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. Seoul Trading Inc.
Food Nol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb. expiration date: 04/17/2013 Class II product 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. Seoul Trading Inc.
Food Na-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. expiration date: 09/23/2013 Class II 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. Seoul Trading Inc.
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