Reported Feb 19, 2020 · Terminated
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the…
C.R. Bard 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: C.R. Bard Inc · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.
- Lot codes and dates
- Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
- Amount recalled
- 1,300 total
Where it was sold
Why it was recalled
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
This product could cause temporary or reversible health problems — stop using it.
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