Device product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Z-2351-2026
Product summary
- Event
- Event 98907
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,005 kits
- Official record key
device-enforcement:Z-2351-2026
Official wording
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Code information: Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342
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.