Z-1219-2020 Class II Terminated
FDA device recall Z-1219-2020 was initiated by C.R. Bard Inc on January 13, 2020 and is designated Class II. 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 m… The recall status is terminated (terminated April 12, 2021). Affected quantity: 1,300 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 13, 2020
- Termination Date
- April 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,300 total
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.
Distribution Pattern
Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Code Information
Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.