Device product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Z-1690-2023
Product summary
- Event
- Event 92283
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1690-2023
Official wording
Reason: Inadvertently released for distibution without sterility assurance.
Code information: Catalog Number: SMA21LPUHJ; Lot Number: 019693
Distribution pattern: Distribution in the US to Georgia
Derived failure modes
-
Unknown
Inadvertently released for distibution without sterility assurance.