Device product
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Z-0779-2021
Product summary
- Event
- Event 86826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88
- Official record key
device-enforcement:Z-0779-2021
Official wording
Reason: The cylindrical sponge component is not x-ray detectable.
Code information: Lot 20GBA365 (Expiration 11/30/2024), 20HBM367 (Expiration 11/30/2024), 20IBC934 (Expiration 11/30/2024)
Distribution pattern: Foreign distribution only - Canada.
Derived failure modes
-
Unknown
The cylindrical sponge component is not x-ray detectable.