Device product
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Z-1041-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 82245
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1041-2019
Official wording
Reason: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Code information: Lot Number 83410S09D
Distribution pattern: The products were distributed to the following US states: CA, NJ, and WA.
Derived failure modes
-
Unknown
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.