FDA recall Z-2530-2025
AVID Medical, Inc. · Class II · device
Product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Reason for recall
Potential for open header bag seals, compromising sterility.
Distribution
US Nationwide distribution in the state of Florida.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-08-04
- Report date
- 2025-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2025