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Milestone S.R.L.: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

Medical DevicesSource: FDA (device) · Date: 2026-05-06

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Milestone S.R.L.
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Reason / hazard
There is a possibility of reagent leakage from the specimen container.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Recall initiated
2026-03-09
Code info
UDI-DI: 08052478981055; Lot Number: 2024-09
Product quantity
61600 units
Voluntary mandated
Voluntary: Firm initiated
City
Sorisole
Country
Italy
Event id
98632
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