FDA DevicesClass II
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Published: June 17, 2026Recall ID: Z-2351-2026Category: 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 20 Fr PULL Model/Catalog Number: 8180-20
Affected Products
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Additional Source Details
| Field | Value |
|---|---|
| City | Alpharetta |
| State | GA |
| Event id | 98907 |
| Address 1 | 5405 Windward Pkwy |
| Address 2 | N/A |
| Code info | Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342 |
| Postal code | 30004-4667 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 6,005 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.