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.
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- October 31, 2016
- Terminated
- November 27, 2017
- Recall Number
- Z-1145-2017
- Quantity
- 33
- Firm Location
- Saint Paul, MN
Reason for Recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Distribution
Internationally to Finland
Lot / Code Info
S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
Root Cause
Labeling mix-ups
Action Taken
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 FCA.Response@Smiths-medical.com. For further questions, please call (651) 633-2556.
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