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.
Reported: February 15, 2017 Initiated: October 31, 2016 #Z-1145-2017
Product Description
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.
Reason for Recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 33
- Distribution
- Internationally to Finland
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smiths Medical ASD, Inc.. Units affected: 33.
Why was this product recalled? ▼
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Low. Recall number: Z-1145-2017.
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