Recall Z-2483-2025 ยท BSB Warmer, Blood, Non-Electromagnetic Radiation
3M Company
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
| Date | Sep 18, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction letter was sent to all their customers on 4/21/2025 to inform them that Solventum [formerly 3M Company] clarified flow rates related to the inlet fluid temperature. The device instructions for use (IFU) will be updated to reflect these changes. Customers are informed that there have been no changes to the design or composition of these products that prompted this notification. Customers are instructed to continue to use the products as indicated, considering the updated information provided in the letter. If the device is used at a flow rate outside of the u |
| Quantity | 530,470 units |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czechia, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER Augustine Medical, Inc., Apr 30, 1998 |