FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard, Pain Pack. Kit Code: AMPK48-01.
- Recall number
- Z-2407-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard, Pain Pack. Kit Code: AMPK48-01.
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-11
- Terminated
- not on file
- Reason
- Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
- Root cause
- Process control
- Action
- AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.
- Quantity
- 120 kits
- Distribution
- US Nationwide distribution in the state of Iowa.
- Lot, serial or model codes
- Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- 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