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.
Recall
- Recall Number
- Z-1145-2017
- Event Number
- 75557
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 2183502
- Product Code
- LGZ
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- October 31, 2016
- Terminated
- November 27, 2017
- Address
- 1265 Grey Fox Rd, Saint Paul, MN, 55112-6929
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.
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Smiths Medical sent an Urgent-Medical Device Field Safety Notice dated October 28, 2016, to all affected customers. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to notify customers and to review and complete the Recall Confirmation Form and return it to Smith Medical via e-mail to [email protected]. For further questions, please call (651) 633-2556.
Internationally to Finland
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