FDAFDA · Food and drugs·Recall number Z-1145-2017
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 conditions.
Published February 15, 2017 · Recall initiated: October 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Internationally to Finland
- Lot
- S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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