FDA Recall
Open, Classified
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Recall: Z-1985-2019
·
Initiated January 17, 2019
Recall
- Recall Number
- Z-1985-2019
- Event Number
- 82967
- Firm
- DJO, LLC
- FEI Number
- 2020737
- Product Code
- JOW
- Status
- Open, Classified
- Root Cause
- Environmental control
- Initiated
- January 17, 2019
- Address
- 1430 Decision, St Vista, CA, 92081-8553
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
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
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.
Distribution
Distributed domestically, Oklahoma
Quantity
9 units