Recall Z-2162-2017 ยท KNT Tubes, Gastrointestinal (And Accessories)
CORPAK MedSystems, Inc.
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.
| Date | Feb 3, 2017 |
| Status | Terminated |
| Reason | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. |
| Root cause | Device Design |
| Action | Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter. |
| Quantity | 2 cases (5 units per case) |
| Distribution | Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Corpak Co., Sep 21, 1988 |