# FDA recall Z-1219-2020

> **C.R. Bard Inc** · Class II · device recall initiated 2020-01-13.

## 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.

## Distribution

Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.

## Key facts

- **Recall number:** Z-1219-2020
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-13
- **Report date:** 2020-02-19
- **Termination date:** 2021-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Covington, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2020

## Citation

> AI Analytics. FDA recall Z-1219-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1219-2020. Source: US FDA. Licensed CC0.

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