Z-2163-2017 Class II Terminated
FDA device recall Z-2163-2017 was initiated by CORPAK MedSystems, Inc. on February 3, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 5, 2019). Affected quantity: 8 cases (2 units per case).
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
- 8 cases (2 units per case)
Product Description
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.
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: 50-6016