FDA Device recall Z-0566-2022
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL by Avanos Medical, citing the External Retention Bolster contained in the kit may be a larger diameter than the tube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0566-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-22 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avanos Medical |
| Distribution | US |
Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Reason
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Identifiers
| code_info | 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0566-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.