DREAMTOME 44-30MM/260CM Material Number: M00584050
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
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 39-30-260-025 Material Number: M00573100
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME RX 39-20-450-025 Material Number: M00573090
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
DREAMTOME 49-20MM/260CM Material Number: M00584000
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
DREAMTOME 49-30MM/450CM Material Number: M00584030
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
JAGTOME RX 49-20-260-035 Material Number: M00573000
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
DREAMTOME 44-30MM/450CM Material Number: M00584070
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Bard Peripheral Vascular
Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Class I - Dangerous
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.
DREAMTOME 49-30MM/260CM Material Number: M00584010
Boston Scientific
Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach