Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Company
- Avid Medical, Inc.
- Recall Initiated
- August 4, 2025
- Posted
- September 5, 2025
- Recall Number
- Z-2530-2025
- Quantity
- 57 units
- Firm Location
- Toano, VA
Reason for Recall
Potential for open header bag seals, compromising sterility.
Distribution
US Nationwide distribution in the state of Florida.
Lot / Code Info
Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
Root Cause
Nonconforming Material/Component
Action Taken
Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.