Recall Z-1219-2020— C.R. Bard Inc

Name: FDA recall Z-1219-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-13

Class II · Terminated

Class II FDA medical device recall by C.R. Bard Inc, initiated 2020-01-13, terminated 2021-04-12. It names one FDA 510(k) clearance: K070201. 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: 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..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Terminated: 2021-04-12
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K070201 — BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001C.R. Bard, Inc.·cleared 2007-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.