3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
FDA Recall #Z-2483-2025 — Class I — April 10, 2025
Product Description
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Reason for Recall
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.
Recalling Firm
3M Company — Saint Paul, MN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product 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, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, UK, and Vietnam.
Code Information
All lots with a manufacturing date after March 2022.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.