Recall Z-1944-2026 ยท NNI Container, Specimen, Non-Sterile
Milestone S.R.L.
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
| Date | Apr 24, 2026 (initiated Mar 9, 2026) |
| Status | Open, Classified |
| Reason | There is a possibility of reagent leakage from the specimen container. |
| Root cause | Under Investigation by firm |
| Action | A RECALL Field Safety Note (FSN) Field Safety Corrective Action (FSCA) dated 3/9/26 was sent to customers. Advice on immediate action to take Contact immediately your distributor. If the LOT/BATCH number reported on the box is the same as the reported above: 1. do not use, neither distribute, REF 68409SS VACUUM BAG SU LARGE; 2. contact immediately your distributor, or Milestone S.P.A.. We warn you to dispose of the unused container present in your stock and not used yet. Milestone will replace them with new ones. Transmit of this Field Safety Notice: This notice needs to be passed on to all |
| Quantity | 61600 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.