VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Recall
- Recall Number
- Z-1944-2026
- Event Number
- 98632
- Firm
- Milestone S.R.L. Via Fatebenefratelli 1/5 Sorisole Italy
- FEI Number
- 1000391282
- Product Code
- NNI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 9, 2026
- Posted
- April 24, 2026
Description
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
There is a possibility of reagent leakage from the specimen container.
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: [email protected]
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
61600 units