FDA DevicesClass II
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Published: February 18, 2026Recall ID: Z-1338-2026Category: devicesCountry: US
Reason for Recall / Hazard
Tyvek bag seal issue which may compromise sterility of the kit.
Product Description & Identification
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98298 |
| Address 1 | 9000 Westmont Dr |
| Address 2 | N/A |
| Code info | Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028 |
| Postal code | 23168-9351 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 1,500 units |
| Reason for recall | Tyvek bag seal issue which may compromise sterility of the kit. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260102 |
| Initial firm notification | |
| Center classification date | 20260209 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of New Jersey.