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

January 17, 2019

Class II

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
reason.no_named_rule · v1.0.0

The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.