—#179246

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.

FDA product code: PHU — Intra-Abdominal Pressure Monitoring Device
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K070201
Affected lot / code info: Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.

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.

Root cause (FDA determination)

Device Design

Action the firm took

Letters were sent 01/13/2020 to the user level instructing the return of two specific product lots of IAP001, Lots NGDQ2943 and NGDS0622.

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2020-01-13
Terminated: 2021-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.