FDA Medical Device Recalls (openFDA)
3M Company: 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
- Recall number
- Z-2483-2025
- Recalling firm
- 3M Company
- Product
- 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
- Status
- Open, Classified
- Initiated
- 2025-04-10
- Posted
- 2025-09-18
- Terminated
- not on file
- 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 updated information provided, there is a potential risk for the device to administer the fluids at a lower temperature than indicated and cause a decrease in patient temperature. Under the dire circumstances of a massive rapid infusion where high flow rates outside of the updated ranges indicated below may be used, there is a potential for hypothermia. Customers with additional questions or need to report an adverse event, are instructed to contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.
- 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.
- Lot, serial or model codes
- All lots with a manufacturing date after March 2022.
- 510(k) numbers
- ["K973741"]
- PMA numbers
- not on file
- Product code
- BSB
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28