FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard LAVH PACK, Model/Catalog Number: USAR053-11
- Recall number
- Z-2964-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11
- Status
- Open, Classified
- Initiated
- 2026-07-10
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.
- Root cause
- Process control
- Action
- Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 7/10/2026 via email. The notice explained the issue, potential risks to health, and requested the following: "ACTIONS TO TAKE: " DO NOT USE AND DISCARD the Clearify Visualization System (Component# 5303907) located in the convenience kit identified in Table 1 above. All other components in the kits may continue to be used. " Add warning labels to affected AVID kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Please contact your Sales Representative if pre-printed labels are needed. " Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " Complete the attached Recall Response Form and return by July 22, 2026."
- Quantity
- 40 packs
- Distribution
- US Nationwide distribution in the state of TX.
- Lot, serial or model codes
- UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OKV
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- 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