ANSM Safety Alert: Manual Ventilator
Summary
The French ANSM has updated a safety alert regarding manual ventilators (Bavu) manufactured by Intersurgical. This update expands the scope of devices affected by a previous safety action initiated in May 2025, with users receiving updated correspondence.
What changed
The French National Agency for Medicines and Health Products Safety (ANSM) has issued an update to a prior safety alert (R2512600) concerning manual ventilators (reanimateurs Bavu) manufactured by Intersurgical. This update, dated March 24, 2026, expands the range of affected devices beyond those initially identified in the May 20, 2025, alert. Healthcare facilities and pharmacies that received the initial notification should review the updated correspondence from Intersurgical.
This action requires healthcare providers to verify if their specific ventilator models are included in the expanded safety action. Compliance officers should ensure that any affected devices are handled according to the instructions provided by Intersurgical, as detailed in the updated correspondence. For specific questions, users are directed to contact Intersurgical directly.
What to do next
- Review updated safety correspondence from Intersurgical regarding manual ventilators.
- Verify if specific ventilator models are included in the expanded safety action.
- Follow instructions provided by Intersurgical for affected devices.
Archived snapshot
Mar 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Information n° R2512600 destinée aux établissements de santé, pharmacies d'usage intérieur
Actualisation du 24/03/2026
L'ANSM a été informée d’un élargissement des dispositifs concernés par une précédente action de sécurité effectuée par la société Intersurgical qui avait été diffusée en mai 2025.
Les utilisateurs concernés ont reçu le nouveau courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2512600.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Intersurgical (24/03/2026)
Information initiale du 20/05/2025
L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Intersurgical.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2512600.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Intersurgical (20/05/2025)
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