États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
CPSCYeeluzan Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Yeeluzan
Yeeluzan Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Yeeluzan
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.
NHTSANova Bus (US) Inc. - Window Glass May Detach from Frame/FMVSS 217
Nova Bus (US) Inc. - Window Glass May Detach from Frame/FMVSS 217
The glass can fall out of the frame, increasing the risk of ejection and injury during a crash. Detached window glass can also become a road hazard for other vehicles, increasing the risk of a crash.
NHTSAWeldon Division of Akron Brass - Touch Screen Display May Fail
Weldon Division of Akron Brass - Touch Screen Display May Fail
A loss of exterior lights can reduce the visibility of the vehicle to other drivers, increasing the risk of a crash. Inoperative equipment can delay emergency response, increasing the risk of injury.
CPSCWybotics Recalls Robotic Pool Vacuums Due to Burn and Fire Hazards
Wybotics Recalls Robotic Pool Vacuums Due to Burn and Fire Hazards
The lithium-ion battery in the recalled pool vacuums can overheat, posing burn and fire hazards to consumers.
USDA FSISFSIS Issues Public Health Alert for Beef and Pork Products Due to Misbranding and Undeclared Allergen
FSIS Issues Public Health Alert for Beef and Pork Products Due to Misbranding and Undeclared Allergen
Misbranding, Unreported Allergens
FDA DeviceseTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesAutomated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
FDA FoodPOPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
FDA DeviceseTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesStryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Surgical light assembly may not adequate support the weight of the ceiling cover.
FDA FoodPOPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
FDA DevicesBurlington Medical, Caps.
Burlington Medical, Caps.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesMEDLINE ANTERIOR HIP PACK DYNJ64672B
MEDLINE ANTERIOR HIP PACK DYNJ64672B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
FDA DevicesAllura Xper FD20/20 OR Table; System Code: 722039;
Allura Xper FD20/20 OR Table; System Code: 722039;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesVue Motion V12. Product Number: 1017979.
Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
FDA DevicesBurlington Medical, Thyroid Shield.
Burlington Medical, Thyroid Shield.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesBurlington Medical, Kilt
Burlington Medical, Kilt
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesAzurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesMiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA DevicesALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
FDA DevicesAzurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA FoodImu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.
Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.
Product is potentially under-processed.
FDA DevicesCPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.