Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients
Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 44-30-260-035 Material Number: M00573060
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 39-30-450-025 Material Number: M00573110
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 44-30-450-035 Material Number: M00573070
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 44-20-450-035 Material Number: M00573050
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 39-30-260-025 Material Number: M00573100
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Bio-Rad Laboratories
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Bio-Rad Laboratories
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
JAGTOME RX 39-20-260-025 Material Number: M00573080
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach