FDA Recalls Hotline Blood and Fluid Warmers for Incorrect Language Labeling
Smiths Medical ASD, Inc. is recalling 33 Hotline Blood and Fluid Warmers distributed to Finland because they included Greek and Danish labeling instead of the required Finnish labeling.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling error regarding language, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 33 units of the Hotline Blood and Fluid Warmer, Model HL-90. This medical device is designed to warm blood and intravenous fluids to normothermic temperatures for delivery to patients under gravity flow conditions.
The recall was initiated because the affected units included Greek and Danish language labeling instead of the required Finnish labeling. The devices were distributed internationally to Finland.
The affected serial numbers are S101B06231-235, S101B06318-325/327, S101B06354-362, and S101B06464-473. Users should contact Smiths Medical ASD, Inc. for further instructions regarding the recall.
The recalled product
- Product
- HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow…
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 33
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)
- S101B06231-235
- S101B06318-325/327
- S101B06354-362
- S101B06464-473.
Distribution
Distribution scope not specified by the agency.
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