Device product
CORFLO PEG Kit, Pull 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.
Z-2163-2017
Product summary
- Event
- Event 76465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 cases (2 units per case)
- Official record key
device-enforcement:Z-2163-2017
Official wording
Reason: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Code information: Catalogue Numbers: 50-6016
Distribution pattern: Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
Derived failure modes
-
Unknown
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.