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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1219-2020

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.

Publicado el 19 de febrero de 2020 · Inicio del retiro: 13 de enero de 2020

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
C.R. Bard Inc
Distribuidor
Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
Lote
Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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