FDA Device recall Z-2161-2017
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm)
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm) by Corpak Medsystems, citing firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2161-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-03 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Corpak Medsystems |
| Distribution | CA, NH, VT |
Product
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
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Identifiers
| code_info | Catalogue Numbers: 50-6112 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2161-2017%22
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