Class II — C.R. Bard Inc
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 | 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. |
| Quantity | 1,300 total |
| Distribution | Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan. |
| Initiated | 2020-01-13 |
| Classified | 2020-02-13 |
| Terminated | 2021-04-12 |
| Recall number | Z-1219-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard Inc (Z-1219-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84744/
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