FDA-Device2020-02-19Class II
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.
C.R. Bard Inc
Hazard
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.
Sold states
Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Affected count
1,300 total
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2020Don't want to check this manually?
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