ANSM Safety Information: Urology/Gynecology Suction Device
Summary
The French ANSM has been informed of a lot recall initiated by Clinical Innovations, LLC for their KIWI Omni Vacuum Delivery System suction device. This safety action is registered under number R2607844 and is directed at pharmacies and healthcare facilities.
What changed
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding a lot recall for the KIWI Omni Vacuum Delivery System, a urology/gynecology suction device manufactured by Clinical Innovations, LLC. The recall action, registered under number R2607844, affects pharmacies and healthcare establishments. Users concerned have been notified directly by the manufacturer.
Healthcare providers using this device should verify if they possess affected lots and follow the instructions provided by Clinical Innovations, LLC. The ANSM directs any questions to the manufacturer. This action highlights the importance of robust post-market surveillance and prompt communication of safety issues within the medical device sector.
What to do next
- Verify if affected lots of the KIWI Omni Vacuum Delivery System are in inventory
- Follow instructions provided by Clinical Innovations, LLC for lot recall
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° R2607844 destinée aux pharmacies d'usage intérieur, établissements de santé L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Clinical Innovations, LLC.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607844.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Clinical Innovations, LLC (24/03/2026)
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