Vacuum Bag SU Large non-sterile specimen container recall
Milestone S.R.L. is recalling Vacuum Bag SU Large non-sterile specimen containers (Model 68409SS) due to the possibility of reagent leakage from the container. The recall affects approximately 61,600 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a specimen container with a potential leakage hazard. The source text does not report any illnesses or injuries, and the hazard is characterized as a "possibility" rather than a confirmed defect, placing it in the Moderate category as a precautionary recall with low-risk contamination potential.
Plain-English summary
Milestone S.R.L. is recalling the Vacuum Bag SU Large, a non-sterile specimen container (Model/Catalog Number 68409SS), due to a possibility of reagent leakage from the container. Lot Number 2024-09 is affected (UDI-DI: 08052478981055).
The recall affects approximately 61,600 units that were distributed worldwide, including throughout the United States and to Canada, Chile, Israel, the United Kingdom, Belgium, Spain, France, Greece, Italy, Luxembourg, the Netherlands, Portugal, and Sweden.
Customers who have received affected units should stop using them and contact Milestone S.R.L. for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
- Manufacturer
- Milestone S.R.L.
- Affected units
- 61,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 08052478981055
- Lot Number: 2024-09
Distribution
Distributed nationwide across the United States.
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