3M Ranger irrigation fluid warming set notice clarifies flow rates
The 3M Ranger Irrigation Fluid Warming Set is subject to a notice issued to clarify flow rates related to the inlet fluid temperature. 186,880 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall consisting of a clarification to the instructions on flow rates, with no device defect or clinical consequence stated.
Plain-English summary
The 3M Ranger Irrigation Fluid Warming Set, REF 24750, SKU 7100235070, UDI/DI 50707387792720 for the box and 10707387792722 for the pouch, is being recalled across all lots with the manufacturing dates listed in the recall notice. The action covers 186,880 units.
The stated reason is that a notice was issued to clarify flow rates related to the inlet fluid temperature. The FDA classified the action as Class II. The source does not describe a device defect or a resulting clinical consequence.
Distribution was nationwide in the United States and to Argentina, Australia, Austria, Belgium and Bosnia and Herzegovina among other markets. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, SKU and UDI codes above and follow the instructions issued by 3M.
The recalled product
- Product
- 3M Ranger Irrigation Fluid Warming Set, REF 24750
- Manufacturer
- 3M Company
- Affected units
- 186,880
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
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