Z-2483-2025Class I

3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

Name: Z-2483-2025 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Creator: 3M Company
Published: 2025-04-10
License: https://open.fda.gov/license/

3M Company / initiated 2025-04-10 / Open, Classified / root cause: design

FDA source

3M Company began a recall of 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 on 2025-04-10. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2483-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-10
Posted: 2025-09-18
Recalling firm: 3M Company
Product: 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Product code: BSB Warmer, Blood, Non-Electromagnetic Radiation
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: All lots with a manufacturing date after March 2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2483-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2483-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18

Product code BSB

K973741Class IIBair Hugger Blood/fluid WarmerAugustine Medical, Inc. / cleared 1998-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)