C.R. Bard Inc recalls The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinar…

Recall date

January 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1219-2020

FDA classification

Class II

Brand / firm

C.R. Bard Inc

Sold / distributed

Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.