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.

Recall Insight

This FDA Devices action (record #Z-1219-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on January 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. C.R. Bard Inc is listed as the recalling firm, operating out of Covington, GA. Federal records indicate 1,300 total units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.