Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA FoodOrganic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen
Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen
Potential E. coli O145:H28 Contamination
FDA FoodIce Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA FoodWY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
Product may contain metal fragments.
FDA DrugsCLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Lack of Assurance of Sterility
NHTSAHiab USA Inc. - Crane Column May Fail
Hiab USA Inc. - Crane Column May Fail
A cracked weld may result in the collapse of the crane column when in use, increasing the risk of injury to the operator or others nearby.
FDA DrugsQC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-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 DevicesABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; 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 DevicesAbiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. 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 DevicesABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. 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 FoodIce Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494
Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA FoodIce Pop, D'Dioses Vainilla, 4 oz (85 g), with UPC 710594511829
Ice Pop, D'Dioses Vainilla, 4 oz (85 g), with UPC 710594511829
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA DevicesBrand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
FDA FoodIce Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487
Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA DevicesABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, 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.
FDA FoodOLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA INGREDIENTS: Pounded Groundnuts (Intwilo) UPC: 650655764330
OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA INGREDIENTS: Pounded Groundnuts (Intwilo) UPC: 650655764330
Undeclared peanuts
FDA FoodIce Pop, D'Dioses Guayaba, 1 Bar (81.7 g), with UPC 827912008432
Ice Pop, D'Dioses Guayaba, 1 Bar (81.7 g), with UPC 827912008432
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA DevicesMedtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
NHTSAAluminum Trailer Company (ATC) - Wireless Remote May Fail to Stop Winch
Aluminum Trailer Company (ATC) - Wireless Remote May Fail to Stop Winch
A winch that operates unintentionally may increase the risk of injury.
FDA FoodIce Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA Devicesda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
FDA DevicesMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
FDA DrugsClinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA FoodIce Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867
Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.