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Recall Observatory FDA recall evidence

Device product

3M Ranger Irrigation Fluid Warming Set, REF 24750

Z-2231-2025

April 22, 2025

Class II

Product summary

Firm
3M Company
Event
Event 97174
Status
Ongoing
Classification
Class II
Quantity
186,880 units
Official record key
device-enforcement:Z-2231-2025

Official wording

Reason: Notice was issued to clarify flow rates related to the inlet fluid temperature.

Code information: UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022

Distribution pattern: US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, 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, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Notice was issued to clarify flow rates related to the inlet fluid temperature.