États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA FoodIce Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531
Ice Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531
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 DevicesRapid Refill Continuous Injection System, UPN M00566001
Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
NHTSACoach and Equipment Mfg. Corp. - Wheelchair Lift May Inadvertently Move
Coach and Equipment Mfg. Corp. - Wheelchair Lift May Inadvertently Move
A wheelchair lift that continues to move while occupied increases the risk of injury.
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.
NHTSADaimler Trucks North America, LLC - Insufficient Illumination from Low Beam Headlights
Daimler Trucks North America, LLC - Insufficient Illumination from Low Beam Headlights
Insufficient low beam headlight illumination can reduce driver visibility, increasing the risk of a crash.
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.
FDA DevicesOrthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
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 DevicesABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0014; 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 DevicesMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
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 DevicesOrthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA DevicesABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, 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 FoodWinfield's CWB Chocolate Bar, packed in clear cello bag with fabric bow on top. Manufactured by CBSL Commissary (DBA Winfield's Chocolate Bar) 9127 Stella Link Rd Houston Texas. Multiple product shapes/sizes: 1) Cat, Net wt. 8oz (226.8g), UPC: 00810079833030, Unit size 5 x 3 1/2 x 2. 2) Teddy Bear, Net wt. 8oz (226.8g), UPC: 00810079833405, Unit size 5 1/2 x 2 1/2 x 2. 3) Easter Bunny, Net wt. 16oz (453.59g), UPC: 00810079837892, Unit size 4 x 1 x 8 1/2.
Winfield's CWB Chocolate Bar, packed in clear cello bag with fabric bow on top. Manufactured by CBSL Commissary (DBA Winfield's Chocolate Bar) 9127 Stella Link Rd Houston Texas. Multiple product shapes/sizes: 1) Cat, Net wt. 8oz (226.8g), UPC: 00810079833030, Unit size 5 x 3 1/2 x 2. 2) Teddy Bear, Net wt. 8oz (226.8g), UPC: 00810079833405, Unit size 5 1/2 x 2 1/2 x 2. 3) Easter Bunny, Net wt. 16oz (453.59g), UPC: 00810079837892, Unit size 4 x 1 x 8 1/2.
Undeclared milk allergen.
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.
FDA DevicesICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
FDA DevicesAbiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 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 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.
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 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 DevicesPhotera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Photera 600, 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 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 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 DevicesOrthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111