3M Ranger Irrigation Fluid Warming Set, REF 24750
Recall
- Recall Number
- Z-2231-2025
- Event Number
- 97174
- Firm
- 3M Company
- FEI Number
- 2110898
- Product Code
- LGZ
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- April 22, 2025
- Posted
- August 1, 2025
- Address
- 2510 Conway Ave E, Building 275-5w-06 3m Center, Saint Paul, MN, 55144-0001
Description
3M Ranger Irrigation Fluid Warming Set, REF 24750
Notice was issued to clarify flow rates related to the inlet fluid temperature.
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 [email protected]. 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.
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, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.
186,880 units