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

Recall date

January 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1985-2019

FDA classification

Class II

Brand / firm

DJO, LLC

Sold / distributed

Distributed domestically, Oklahoma

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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