3M Ranger Blood/Fluid Warming Sets recalled for clarification on operating parameters
3M Company recalled 530,470 units of Ranger Blood/Fluid Warming High Flow Sets worldwide due to unclear documentation about flow rates and temperature parameters. The field action aims to clarify outlet temperature location and inlet fluid temperatures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as a Class I recall by the FDA. Per the severity rubric, FDA Class I recalls require a minimum severity of 4 (Severe). No deaths, serious injuries, or hospitalizations are reported in the source material. The recall aims to clarify operational parameters to prevent potential patient harm from improper device use.
Plain-English summary
3M Company is recalling 530,470 units of its Ranger Blood/Fluid Warming High Flow Set (Catalog Numbers 24355, 24370) in a Class I field action. These are devices used to warm blood and intravenous fluids in healthcare settings.
The recall addresses documentation and clarity regarding the product's operational parameters. Specifically, the manufacturer is providing clarification on flow rates, inlet fluid temperatures, and the location of the outlet temperature sensor on these devices.
The affected units were distributed worldwide, including throughout the United States and Puerto Rico, as well as numerous other countries. All lots with a manufacturing date after March 2022 are included in the recall.
This Class I recall affects healthcare facilities and medical professionals worldwide who rely on these warming sets. Proper understanding and implementation of the clarified operating parameters is critical for the safe and effective operation of this equipment.
The recalled product
- Product
- 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
- Manufacturer
- 3M Company
- Hazard
- 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 (1)
- All lots with a manufacturing date after March 2022.
Distribution
Distributed nationwide across the United States.
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