Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
- Company
- Avid Medical, Inc.
- Recall Initiated
- November 14, 2025
- Posted
- December 15, 2025
- Recall Number
- Z-0929-2026
- Quantity
- 90 units
- Firm Location
- Toano, VA
Reason for Recall
Potential for incomplete seal on header bag.
Distribution
US distribution to GA, IL, NE, MD.
Lot / Code Info
Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.
Root Cause
Nonconforming Material/Component
Action Taken
AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.