FDA Medical Device Recalls (openFDA)
C.R. Bard Inc: 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 number
- Z-1219-2020
- Recalling firm
- C.R. Bard Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-01-13
- Posted
- not on file
- Terminated
- 2021-04-12
- 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.
- Root cause
- Device Design
- Action
- Letters were sent 01/13/2020 to the user level instructing the return of two specific product lots of IAP001, Lots NGDQ2943 and NGDS0622.
- Quantity
- 1,300 total
- Distribution
- Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
- Lot, serial or model codes
- Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
- 510(k) numbers
- ["K070201"]
- PMA numbers
- not on file
- Product code
- PHU
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28