Recall Z-1985-2019
Djo, LLC · initiated January 17, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Codes / lots: Lot # 418003 UDI: (01)00888912302418
Reason for recall
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
FDA-determined cause: Environmental control
Action taken
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.
Details
- Recall number
- Z-1985-2019
- Initiated
- January 17, 2019
- Product code
- JOW – Sleeve, Limb, Compressible
- Quantity
- 9 units
- Distribution
- Distributed domestically, Oklahoma
- Recalling firm
- Djo, LLC, Vista, CA