Blood and fluid warming sets recalled to clarify flow rates and temperatures
3M Ranger Blood/Fluid Warming High Flow Sets are the subject of a field action to clarify flow rates, inlet fluid temperatures and the location of the outlet temperature. The FDA classified it as Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I action, and the FDA classified this blood and fluid warming set field action as Class I.
Plain-English summary
3M Ranger Blood/Fluid Warming High Flow Sets, catalog numbers 24355 and 24370, are being recalled across all lots with a manufacturing date after March 2022. The recall covers 530,470 units distributed in the United States including Puerto Rico and in many other countries.
The action is a field action to clarify the flow rates and inlet fluid temperatures, along with the location of the outlet temperature, for Ranger Blood/Fluid Warming High Flow Sets. The FDA classified the action as Class I, its most serious category.
Hospitals using these sets should follow the manufacturer's updated instructions for use.
The recalled product
- Product
- 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
- Manufacturer
- 3M Company
- Category
- Medical Device — Fluid Warming
- Affected units
- 530,470
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 (1)
- All lots with a manufacturing date after March 2022.
Distribution
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