FDA Device recall Z-0371-2020
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could…
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could… by Avanos Medical, citing the connector piece to the PEG tube does not pass over the guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0371-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-08 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Avanos Medical |
| Distribution | CT, IN, MD, NJ, PA, VA |
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
The connector piece to the PEG tube does not pass over the guidewire.
Identifiers
| code_info | Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0371-2020%22
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