ConvaTec, Inc recalls AbViser AutoValve IAP (intra- abdominal pressure) Monitoring
Recalled Product
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.
Hazard / Issue
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
Issued by
FDA
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