Boston Scientific JAGTOME RX 39-30-450-025 Material Number: M00573110 recall — FDA Z-0772-2022
Sterility of device is compromised due to a sterile barrier breach
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The newest recall records with useful source details are listed here.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
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…
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…
Sterility of device is compromised due to a sterile barrier breach
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…
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…
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to…
Sterility of device is compromised due to a sterile barrier breach
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Browse recent months with enough recall history for useful comparison.