Device product
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Z-0783-2021
Product summary
- Event
- Event 86826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360
- Official record key
device-enforcement:Z-0783-2021
Official wording
Reason: The cylindrical sponge component is not x-ray detectable.
Code information: Lot 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)
Distribution pattern: Foreign distribution only - Canada.
Derived failure modes
-
Unknown
The cylindrical sponge component is not x-ray detectable.