Z-2407-2026 Class II Ongoing
FDA device recall Z-2407-2026 was initiated by AVID Medical, Inc. on April 30, 2026 and is designated Class II. Reason for recall: Inadvertent distribution of sealed pouches that had not undergone validated sterilization. The recall status is ongoing. Affected quantity: 120 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 kits
Product Description
Halyard, Pain Pack. Kit Code: AMPK48-01.
Reason for Recall
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Distribution Pattern
US Nationwide distribution in the state of Iowa.
Code Information
Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.