FDA DevicesClass II
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409...
Published: May 6, 2026Recall ID: Z-1944-2026Category: devicesCountry: US
Reason for Recall / Hazard
There is a possibility of reagent leakage from the specimen container.
Product Description & Identification
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Additional Source Details
| Field | Value |
|---|---|
| City | Sorisole |
| Event id | 98632 |
| Address 1 | Via Fatebenefratelli 1/5 |
| Code info | UDI-DI: 08052478981055; Lot Number: 2024-09 |
| Postal code | N/A |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 61600 units |
| Reason for recall | There is a possibility of reagent leakage from the specimen container. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260309 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260424 |
Overview
- Recalling FirmMilestone S.R.L.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.