medical Class II Updated 2020-02-19

C.R. Bard Inc recalls The Bard Intra-abdominal Pressure Monitoring Device is compo

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
View official government recall

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