FDA recall Z-1985-2019

DJO, LLC · Class II · 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.

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

Distributed domestically, Oklahoma

Key facts

Status
Ongoing
Initiation date
2019-01-17
Report date
2019-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vista, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2019