Z-1985-2019 Class II Ongoing

Recalled by DJO, LLC — Vista, CA

Recall Details

Product Type
Devices
Report Date
July 24, 2019
Initiation Date
January 17, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

Reason for Recall

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

Distribution Pattern

Distributed domestically, Oklahoma

Code Information

Lot # 418003 UDI: (01)00888912302418