Z-2231-2025Class II

3M Ranger Irrigation Fluid Warming Set, REF 24750

Name: Z-2231-2025 3M Ranger Irrigation Fluid Warming Set, REF 24750
Creator: 3M Company
Published: 2025-04-22
License: https://open.fda.gov/license/

3M Company / initiated 2025-04-22 / Open, Classified / root cause: design

FDA source

3M Company began a recall of 3M Ranger Irrigation Fluid Warming Set, REF 24750 on 2025-04-22. FDA classified it as Class II and gives the reason as "Notice was issued to clarify flow rates related to the inlet fluid temperature". 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-2231-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-22
Posted: 2025-08-01
Recalling firm: 3M Company
Product: 3M Ranger Irrigation Fluid Warming Set, REF 24750
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: Notice was issued to clarify flow rates related to the inlet fluid temperature.
Root cause tag: design
FDA root cause: Device Design
Action: Solventum 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 [email protected]. 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 commerce: 186,880 units
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.
Product codes and lots: UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, 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-2231-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2231-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

Product code LGZ

K060939Class IIRanger Irrigation Fluid Warming SystemArizant Healthcare, Inc. / cleared 2006-06-26

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)