Device product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Z-1944-2026
Product summary
- Firm
- Milestone S.R.L.
- Event
- Event 98632
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61600 units
- Official record key
device-enforcement:Z-1944-2026
Official wording
Reason: There is a possibility of reagent leakage from the specimen container.
Code information: UDI-DI: 08052478981055; Lot Number: 2024-09
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Derived failure modes
-
Unknown
There is a possibility of reagent leakage from the specimen container.