Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FDA DrugsFoster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DrugsGOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesArterial Line Kit 20ga x 6, REF: 400115A
Arterial Line Kit 20ga x 6, REF: 400115A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA DevicesTransvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA Drugsmeijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DrugsCVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
FDA DevicesOptima XR200amx, Mobile Digital-Ready Radiographic System
Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
FDA DrugsTopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesGeneral Biospy Tray, REF: GUTS1000
General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA DevicesOlympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA DrugsAUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesOlympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA DevicesOne-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
NHTSAThe Heil Co. - Water in High Voltage Cabinet May Cause Short Circuit
The Heil Co. - Water in High Voltage Cabinet May Cause Short Circuit
Electrical component failure may lead to an unexpected vehicle shutdown, increasing the risk of a crash. In addition, an electrical short increases the risk of a fire.
FDA DevicesPhotera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
FDA DrugsCAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
FDA DrugsBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
FDA DrugsFAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesPapablic Replacement Brush Heads. Model Number: PAPA317AA.
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
FDA DrugsLEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.