États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesBurlington Medical, Kilt Blockers.
Burlington Medical, Kilt Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesMedline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
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 DevicesCPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA DevicesAllura Xper FD20/10; System Code: 722029;
Allura Xper FD20/10; System Code: 722029;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesBurlington Medical, Wrap Aprons.
Burlington Medical, Wrap Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DrugsMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
FDA DevicesBurlington Medical, Protective Sleeves.
Burlington Medical, Protective Sleeves.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesMiniMed 530G Insulin Pump (MMT-551, MMT-751)
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
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 DrugsPrazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
FDA DeviceseTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
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 DevicesSIGNA Premier systems
SIGNA Premier systems
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
FDA DevicesBD Kiestra" ReadA; Catalog No.: 446948.
BD Kiestra" ReadA; Catalog No.: 446948.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
FDA DrugsPrazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
FDA Devices2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
FDA DevicesPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
FDA FoodSpray Dried Dairy Powder 25 kg bags or 1 metric ton totes
Spray Dried Dairy Powder 25 kg bags or 1 metric ton totes
Salmonella spp. identified in finished product testing
FDA DevicesMiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
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 DevicesParadigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
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 DeviceseTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
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 DevicesJiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
FDA DevicesMiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
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 FD10F; System Code: 722002;
ALLURA Xper FD10F; System Code: 722002;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DeviceseTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
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.