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 Recall Z-1219-2020 · Posted None
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Recalling FirmC.R. Bard Inc
Recall StatusTerminated
Product CodePHU
Date Initiated2020-01-13
Date Terminated2021-04-12
Product Quantity1,300 total
Reason for Recall
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.
Firm Action
Letters were sent 01/13/2020 to the user level instructing the return of two specific product lots of IAP001, Lots NGDQ2943 and NGDS0622.
Root Cause
Device Design
Distribution Pattern
Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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