Device product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No
Z-2347-2026
Product summary
- Event
- Event 98907
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 kits
- Official record key
device-enforcement:Z-2347-2026
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 10350770007813, Lot Number 30370718
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.