Aircast recall: Sterility Concern
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Why was Aircast recalled?
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 418003 UDI: (01)00888912302418
- Product
- Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
- Recalling firm
- DJO, LLC
- Quantity
- 9 units
- Distribution
- Distributed domestically, Oklahoma
- Recall date
- July 24, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)