Z-1985-2019 Class II Ongoing
FDA device recall Z-1985-2019 was initiated by DJO, LLC on January 17, 2019 and is designated Class II. Reason for recall: The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements. The recall status is ongoing. Affected quantity: 9 units.
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