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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1357-2018

Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.

Publicado el 18 de abril de 2018 · Inicio del retiro: 27 de febrero de 2018

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

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
C.R. Bard, Inc.
Distribuidor
US Nationwide Distribution
Lote
Lot Numbers: NGBN2862, NGAXX217, NGAVX225
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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