FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1985-2019
- Recalling firm
- DJO, LLC
- Product
- Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
- Status
- Open, Classified
- Initiated
- 2019-01-17
- Posted
- not on file
- Terminated
- not on file
- 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
- Lot, serial or model codes
- Lot # 418003 UDI: (01)00888912302418
- 510(k) numbers
- K964238
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 2020737
- Firm city
- Vista
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28