3M Ranger Irrigation Fluid Warming Set Flow Rate Clarification Notice
FDA issued a clarification notice for 3M Ranger Irrigation Fluid Warming Sets regarding flow rates related to inlet fluid temperature. Approximately 186,880 units distributed in the US and 48 other countries are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall involving a clarification notice about flow rates. No illnesses, injuries, or hospitalizations have been reported. The issue appears to be documentation or specification clarification rather than an imminent safety emergency, consistent with a voluntary precautionary recall.
Plain-English summary
The FDA has issued a clarification notice for the 3M Ranger Irrigation Fluid Warming Set (REF 24750) to address flow rates related to inlet fluid temperature. The recall affects approximately 186,880 units distributed in the United States and internationally, including Canada, Western Europe, Australia, and other territories.
The manufacturer, 3M Company, is clarifying specifications for affected units with manufacturing dates after March 2022, identified by UDI/DI 50707387792720 and 10707387792722, and SKU 7100235070. Healthcare facilities and medical professionals using this device should review the clarification notice to ensure proper flow rate settings during irrigation fluid warming procedures.
Consumers and healthcare providers should contact 3M Company for detailed guidance on the clarification and any necessary adjustments to device use or operation.
The recalled product
- Product
- 3M Ranger Irrigation Fluid Warming Set, REF 24750
- Manufacturer
- 3M Company
- Hazard
- flow-rate-documentation
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 50707387792720 (box)
- 10707387792722 (pouch
- )SKU 7100235070
- All lots with a manufacturing date after March 2022
Distribution
Distributed nationwide across the United States.
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