FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
- Recall number
- Z-1338-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
- Status
- Open, Classified
- Initiated
- 2026-01-02
- Posted
- 2026-02-09
- Terminated
- not on file
- Reason
- Tyvek bag seal issue which may compromise sterility of the kit.
- Root cause
- Equipment maintenance
- Action
- AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed.
- Quantity
- 1,500 units
- Distribution
- US Nationwide distribution in the states of New Jersey.
- Lot, serial or model codes
- Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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