Class II — Avanos Medical, Inc.
| Recalling firm | Avanos Medical, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The connector piece to the PEG tube does not pass over the guidewire. |
| 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. |
| Quantity | 104 cases (208 units) total |
| Distribution | Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain. |
| Initiated | 2019-10-08 |
| Classified | 2019-11-14 |
| Terminated | 2022-03-16 |
| Recall number | Z-0371-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Avanos Medical, Inc. (Z-0371-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84021/
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