Z-1219-2020Class II

The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into...

Name: Z-1219-2020 The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into...
Creator: C.R. Bard Inc
Published: 2020-01-13
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2020-01-13 / Terminated / root cause: design

FDA source

C.R. Bard Inc began a recall of 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... on 2020-01-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1219-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-03-02
Terminated: 2021-04-12
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.
Product code: PHU Intra-Abdominal Pressure Monitoring Device
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.
Root cause tag: design
FDA 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 in commerce: 1,300 total
Distribution: Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Product codes and lots: Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13

Product code PHU

K070201UnclassifiedBard Intra-Abdominal Pressure Monitoring Device, Model Iap-001C.R. Bard, Inc. / cleared 2007-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)