Z-2161-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- February 3, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 cases (5 units per case)
Product Description
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); 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.
Reason for Recall
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Distribution Pattern
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
Code Information
Catalogue Numbers: 50-6112