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.
FDA Recall Z-1145-2017 · Posted None
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeLGZ
Date Initiated2016-10-31
Date Terminated2017-11-27
Product Quantity33
Reason for Recall
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Internationally to Finland
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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