Device product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Z-2350-2026
Product summary
- Event
- Event 98907
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 218 kits
- Official record key
device-enforcement:Z-2350-2026
Official wording
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Code information: UDI-DI 10350770007844, Lot Numbers 30371318, 30375469, 30383056
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.