Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. 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 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.
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 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 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.
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 FoodRuby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry conditions .
Ruby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry conditions .
Foreign material (Glass) was found in the product.
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 Rompope, 4 oz (85 g), with UPC 710594511812
Ice Pop, D'Dioses Rompope, 4 oz (85 g), with UPC 710594511812
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA FoodPillsbury Bread Rolls, Kaiser Roll Dough. 144 units / 2.5oz each. Net Wt. 22.5 lb (10.2kg) Package UPC 7 21582-13288 9. Case UPC 107-21582-13288-6. Keep Frozen. Case Qty 144. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440.
Pillsbury Bread Rolls, Kaiser Roll Dough. 144 units / 2.5oz each. Net Wt. 22.5 lb (10.2kg) Package UPC 7 21582-13288 9. Case UPC 107-21582-13288-6. Keep Frozen. Case Qty 144. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440.
Potential foreign material (glass)
FDA DrugsNystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
FDA FoodPillsbury Bread Rolls, Hard Roll Dough. 180 units / 2.25oz each. Net Wt. 25.31 lb (11.48kg) Package UPC 721582-13283 4. Case UPC 107-21582-13283-1. Keep Frozen. Case Qty 180. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440.
Pillsbury Bread Rolls, Hard Roll Dough. 180 units / 2.25oz each. Net Wt. 25.31 lb (11.48kg) Package UPC 721582-13283 4. Case UPC 107-21582-13283-1. Keep Frozen. Case Qty 180. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440.
Potential foreign material (glass)
FDA DevicesOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
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.
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 DevicesMedtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
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 DevicesABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. 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.
NHTSAVolkswagen Group of America, Inc. - Rearview Camera Image May Not Display
Volkswagen Group of America, Inc. - Rearview Camera Image May Not Display
A rearview camera that fails to display an image can reduce the driver’s view behind the vehicle, increasing the risk of a crash.
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 DevicesPapablic Replacement Brush Heads. Model Number: PAPA317AA.
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
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 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 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.
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%).