Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Reported: July 24, 2019 Initiated: January 17, 2019 #Z-1985-2019
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.
Details
- Recalling Firm
- DJO, LLC
- Units Affected
- 9 units
- Distribution
- Distributed domestically, Oklahoma
- Location
- Vista, CA
Frequently Asked Questions
What product 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.. Recalled by DJO, LLC. Units affected: 9 units.
Why was this product recalled? ▼
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1985-2019.
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