Recall Z-2231-2025

Reason for recall

Notice was issued to clarify flow rates related to the inlet fluid temperature.

FDA-determined cause: Device Design

Action taken

Solventum issued an Urgent Medical Device Correction notice dated 04/21/2025 to its consignees via email and US certified mail. The notice explained the issue, the modification related to the inlet fluid temperature to address the issue, and forthcoming instructions for use updates. All users of the impacted products are being asked to take the following actions. " Ensure this notification is passed on to all those who need to be aware within your organization and to any department where the affected products have been transferred. " Continue to use the products as indicated, considering the updated information provided. " Keep this notice on hand until you are notified that the updated IFUs and operator s manuals are available. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the updated information provided. " Email the completed form to 3MFieldSafetyAction@montage72.com. For additional questions or need to report an adverse event, contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.