FDA DevicesClass II
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Published: June 17, 2026Recall ID: Z-2350-2026Category: devicesCountry: US
Reason for Recall / Hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Description & Identification
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Affected Products
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Additional Source Details
| Field | Value |
|---|---|
| City | Alpharetta |
| State | GA |
| Event id | 98907 |
| Address 1 | 5405 Windward Pkwy |
| Address 2 | N/A |
| Code info | UDI-DI 10350770007844, Lot Numbers 30371318, 30375469, 30383056 |
| Postal code | 30004-4667 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 218 kits |
| Reason for recall | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | N/A |
| Center classification date | 20260605 |
Overview
- Recalling FirmAvanos Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.