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Priority review Notice Amended Final

ANSM Safety Alert: Space Plus Perfusor Syringe Pump by B Braun

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Detected March 23rd, 2026
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Summary

The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued a safety alert regarding the Space Plus Perfusor syringe pump manufactured by B Braun Melsungen AG. This alert informs healthcare facilities and pharmacies about a safety action implemented by the manufacturer.

What changed

The ANSM has alerted healthcare providers and pharmacies in France about a safety action concerning the Space Plus Perfusor syringe pump from B Braun Melsungen AG. The alert, registered under number R2607233, directs concerned users to a letter from the manufacturer for specific details.

Healthcare facilities and pharmacies that use this device should review the manufacturer's safety action letter to understand any required steps or implications. For direct inquiries, users are instructed to contact B Braun Melsungen AG, the issuer of the safety action. The ANSM acts as the informing body for this manufacturer-led safety initiative.

What to do next

  1. Review the B Braun Melsungen AG safety action letter for the Space Plus Perfusor syringe pump.
  2. Contact B Braun Melsungen AG directly for any questions regarding the safety action.

Source document (simplified)

A+ A-

Information n° R2607233 destinée aux pharmacies d'usage intérieur et établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société B Braun Melsungen AG.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607233. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société B Braun Melsungen AG (23/03/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive
Document ID
Information n° R2607233

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Safety
Geographic scope
France FR

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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