3M Ranger Irrigation Fluid Warming Set, REF 24750

FDA device recall Z-2231-2025 · posted 2025-08-01 · Open, Classified

Recall details

Recalling firm

3M Company

Reason for recall

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

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.

Root cause

Device Design

Status

Open, Classified

Product code

LGZ

Quantity affected

186,880 units

Distribution

US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana

Date initiated

2025-04-22

Date posted

2025-08-01

Location

Saint Paul, MN

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