FDAFDA · Food and drugs·Recall number Z-1985-2019
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Published July 24, 2019 · Recall initiated: January 17, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DJO, LLC
- Distributor
- Distributed domestically, Oklahoma
- Lot
- Lot # 418003 UDI: (01)00888912302418
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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