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Z-2483-2025 Class I Ongoing

Recalled by 3M Company — Saint Paul, MN

FDA device recall Z-2483-2025 was initiated by 3M Company on April 10, 2025 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 530,470 units.

Recall Details

Product Type: Devices
Report Date: September 24, 2025
Initiation Date: April 10, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 530,470 units

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.

Distribution Pattern

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.