Device product
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Z-1985-2019
Product summary
- Firm
- DJO, LLC
- Event
- Event 82967
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1985-2019
Official wording
Reason: The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Code information: Lot # 418003 UDI: (01)00888912302418
Distribution pattern: Distributed domestically, Oklahoma
Derived failure modes
-
Unknown
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.