CORFLO* Percutaneous Endoscopic Gastrostomy — Class II medical device recall Z-0371-2020
Terminated recall by Avanos Medical, Inc., reported 2019-11-20, distributed in CT, IN, MD, NJ, PA, VA. The connector piece to the PEG tube does not pass over the guidewire.
| Recall number | Z-0371-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2019-10-08 |
| Classified | 2019-11-14 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2022-03-16 |
| Distributed | CT, IN, MD, NJ, PA, VA |
| Countries outside the US | GB |
| Lot numbers | 0203069043, 0203137961, 0203172166 |
| Model numbers | 50-4016E1, 50-4020E1 |
Product
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
Reason for recall
The connector piece to the PEG tube does not pass over the guidewire.
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-0371-2020. 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.