Recall Z-2231-2025 ยท LGZ Warmer, Thermal, Infusion Fluid
3M Company
3M Ranger Irrigation Fluid Warming Set, REF 24750
| Date | Aug 1, 2025 (initiated Apr 22, 2025) |
| Status | Open, Classified |
| Reason | Notice was issued to clarify flow rates related to the inlet fluid temperature. |
| Root cause | Device Design |
| Action | 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 t |
| Quantity | 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, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM Arizant Healthcare, Inc., Jun 26, 2006 |