FDA-Device2019-07-24Class II

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

DJO, LLC
Hazard

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

Sold states
Distributed domestically, Oklahoma
Affected count
9 units
Manufactured in
1430 Decision St, N/A, Vista, CA, United States
Products
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

Official notice

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

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