FDA Enforcement
Class II
Ongoing
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Recall: Z-1944-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-1944-2026
- Event ID
- 98632
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Milestone S.R.L.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 6, 2026
- Initiation Date
- March 9, 2026
- Classification Date
- April 24, 2026
- Address
- Via Fatebenefratelli 1/5, Sorisole, N/A, Italy
Description
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Reason
There is a possibility of reagent leakage from the specimen container.
Code Info
UDI-DI: 08052478981055; Lot Number: 2024-09
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Quantity
61600 units