FDA Enforcement Class II Ongoing

3M Ranger Irrigation Fluid Warming Set, REF 24750

Recall: Z-2231-2025 · Reported August 6, 2025

Enforcement

Recall Number
Z-2231-2025
Event ID
97174
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
3M Company
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
August 6, 2025
Initiation Date
April 22, 2025
Classification Date
July 31, 2025
Address
2510 Conway Ave E, 3m Center, Building 275-5w-06, Saint Paul, MN, 55144-0001, United States

Description

3M Ranger Irrigation Fluid Warming Set, REF 24750

Reason

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

Code Info

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

Distribution

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.

Quantity

186,880 units