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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Ranger

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 Class 2 Device Recall 3M Rangersee related information
Date Initiated by FirmApril 22, 2025
Date PostedAugust 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2231-2025
Recall Event ID 97174
510(K)NumberK060939 
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
Product3M Ranger Irrigation Fluid Warming Set, REF 24750
Code Information UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022
Recalling Firm/
Manufacturer		 3M Company
2510 Conway Ave E
3m Center, Building 275-5w-06
Saint Paul MN 55144-0001
For Additional Information ContactAshish Patel
619-854-1204
Manufacturer Reason
for Recall		Notice was issued to clarify flow rates related to the inlet fluid temperature.
FDA Determined
Cause 2		Device Design
ActionSolventum issued an Urgent Medical Device Correction notice dated 04/21/2025 to its consignees via email and US certified mail. The notice explained the issue, the modification related to the inlet fluid temperature to address the issue, and forthcoming instructions for use updates. All users of the impacted products are being asked to take the following actions. " Ensure this notification is passed on to all those who need to be aware within your organization and to any department where the affected products have been transferred. " Continue to use the products as indicated, considering the updated information provided. " Keep this notice on hand until you are notified that the updated IFUs and operator s manuals are available. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the updated information provided. " Email the completed form to 3MFieldSafetyAction@montage72.com. For additional questions or need to report an adverse event, contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.
Quantity in Commerce186,880 units
DistributionUS (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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LGZ
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