FDA DevicesClass II
Halyard, Pain Pack. Kit Code: AMPK48-01.
Published: June 17, 2026Recall ID: Z-2407-2026Category: devicesCountry: US
Reason for Recall / Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Product Description & Identification
Halyard, Pain Pack. Kit Code: AMPK48-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 99021 |
| Address 1 | 9000 Westmont Dr |
| Address 2 | N/A |
| Code info | Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028. |
| Postal code | 23168-9351 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 120 kits |
| Reason for recall | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | |
| Center classification date | 20260611 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of Iowa.