Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units
Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.
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: The recall is classified as FDA Class II, and the hazard involves a component becoming unusable rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 2,247 units of the HOTLINE 3 Blood and Fluid Warmer (Reorder No. HL-390). The recall covers all serial numbers and affects units distributed nationwide in the United States.
The recall was initiated because the disposable microswitch on the device may become damaged and unusable if it is not correctly installed. This product is intended for use by appropriately trained healthcare professionals in clinical environments to deliver warmed blood and intravenous fluids at normothermic temperatures.
Healthcare facilities should stop using the affected devices and contact Smiths Medical ASD, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blo
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 2,247
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 serial numbers
Distribution
Distributed nationwide across the United States.
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