Milestone S.R.L. recalls VACUUM BAG SU LARGE

There is a possibility of reagent leakage from the specimen container.

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

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 those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents to Milestone S.P.A. (at the e-mail address reported below), distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback. If you have further questions, do not hesitate to contact us: regulatory@milestonesrl.com

• FDA enforcement recordOfficial FDA database entry for Z-1944-2026
• FDA device classification · NNIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.3250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Milestone S.R.L.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.