ANSM Safety Alert: B. Braun Infusion Sets and Mentor Tissue Expanders

ANSM Drug & Device Safety Alerts

Published March 18th, 2026

Detected March 18th, 2026

Summary

The ANSM has issued a safety alert regarding specific lots of B. Braun infusion sets and Mentor tissue expanders. A lot recall has been implemented by the manufacturer, B. Braun Medical Inc., and Mentor. Affected users have been notified.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert (Information n° R2606326) concerning specific lots of B. Braun infusion sets (calibre 21) and Mentor CPX-4 tissue expanders. This alert follows the implementation of a lot recall by B. Braun Medical Inc. and Mentor. The document indicates that affected users have received direct communication from the manufacturer.

Healthcare providers, particularly those in hospital pharmacies and community care settings, should be aware of this recall. While the ANSM directs inquiries to the manufacturer, entities should ensure they have identified and removed the affected lots from their inventory. The alert references a letter from B. Braun Medical Inc., Mentor dated March 18, 2026, which likely contains specific details on the affected lots and return procedures.

What to do next

Verify if specific lots of B. Braun infusion sets and Mentor tissue expanders are in inventory.
Consult the manufacturer's recall letter for specific lot numbers and return instructions.
Remove affected product lots from use and return them according to manufacturer guidelines.

Source document (simplified)

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Information n° R2606326 destinée aux pharmacies d'usage intérieur, structures de soins de ville, grandes et moyennes surfaces L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société B. Braun Medical Inc., Mentor.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606326.

Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société B. Braun Medical Inc., Mentor (18/03/2026)