Recall Z-1985-2019 ยท JOW Sleeve, Limb, Compressible
DJO, LLC
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
| Date | Jan 17, 2019 |
| Status | Open, Classified |
| Reason | The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements. |
| Root cause | Environmental control |
| 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. |
| Quantity | 9 units |
| Distribution | Distributed domestically, Oklahoma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS Aircast, Inc., Sep 8, 1997 |