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Recall Observatory FDA recall evidence

Device product

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

Z-2483-2025

April 10, 2025

Class I

Product summary

Firm
3M Company
Event
Event 96841
Status
Ongoing
Classification
Class I
Quantity
530,470 units
Official record key
device-enforcement:Z-2483-2025

Official wording

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.

Code information: All lots with a manufacturing date after March 2022.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.