The Bard Intra-abdominal Pressure Monitoring Device is composed of a… — Class II medical device recall Z-1219-2020
Terminated recall by C.R. Bard Inc, reported 2020-02-19, distributed nationwide. Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead
| Recall number | Z-1219-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2020-01-13 |
| Classified | 2020-02-13 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, JP |
| Quantity | 1,300 total |
| Reason classes | packaging |
| Lot numbers | NGDQ2943, NGDS0622 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1219-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.