FDAFDA · Alimentos y medicamentos·N.º oficial Z-2162-2017
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Publicado el 31 de mayo de 2017 · Inicio del retiro: 3 de febrero de 2017
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
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- CORPAK MedSystems, Inc.
- Distribuidor
- Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
- Lote
- Catalogue Numbers: 50-6116
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States