Recall Z-1985-2019— DJO, LLC

Name: FDA recall Z-1985-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-17

Class II · Ongoing

Class II FDA medical device recall by DJO, LLC, initiated 2019-01-17. It names one FDA 510(k) clearance: K964238. 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: The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements..

Recalling firm: DJO, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-01-17
Firm location: Vista, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K964238 — AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSAircast, Inc.·cleared 1997-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.