Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
FDA Recall Z-1985-2019 · Posted None
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Recalling FirmDJO, LLC
Recall StatusOpen, Classified
Product CodeJOW
Date Initiated2019-01-17
Product Quantity9 units
Reason for Recall
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Firm Action
On January 18, 2019 a Urgent: Medical Device Recall letter was sent via email to customers. The letter ask all customers to send the notification to all customers who have purchased or were issued the affected product. In addition, the letter request that the customer complete the "Return Response" form by February 15, 2019. If you have any additional questions, please contact the firm at 1-800-321-9549.
Root Cause
Environmental control
Distribution Pattern
Distributed domestically, Oklahoma
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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