FDAFDA · Food and drugs·Recall number 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.
Published May 31, 2017 · Recall initiated: February 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CORPAK MedSystems, Inc.
- Distributor
- Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
- Lot
- Catalogue Numbers: 50-6116
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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