CORFLO — Class II medical device recall Z-2161-2017
Terminated recall by CORPAK MedSystems, Inc., reported 2017-05-31, distributed in CA, NH, VT. Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may bre
| Recall number | Z-2161-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CORPAK MedSystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2017-02-03 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2019-08-05 |
| Distributed | CA, NH, VT |
| Countries outside the US | AT, FR, GB, IE, NO, NZ, SE |
| Reason classes | device malfunction |
| Model numbers | 50-6112 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2161-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.