Reported Aug 22, 2018 · Terminated
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device
- Patient mounta) 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
- Lot codes and dates
- a) ABV 300Lot
- Number 150924 b) ABV 301Lot
- Numbers
160937161023161128170120170514170732170801170829
- Amount recalled
- 3881 units
Where it was sold
- Nationwide
Why it was recalled
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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