C.R. Bard Inc: Medical Device Recall in 2020 - (Recall #: Z-1219-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
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.
Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Voluntary: Firm initiated