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U.S. Department of Health and Human Services

Class 3 Device Recall HOTLINE Blood and Fluid Warmer, Mole l HL90

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  Class 3 Device Recall HOTLINE Blood and Fluid Warmer, Mole l HL90 see related information
Date Initiated by Firm October 31, 2016
Create Date February 07, 2017
Recall Status1 Terminated 3 on November 27, 2017
Recall Number Z-1145-2017
Recall Event ID 75557
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
Product 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.
Code Information S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.  
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Smiths Medical Representative
651-633-2556
Manufacturer Reason
for Recall		 HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
FDA Determined
Cause 2		 Labeling mix-ups
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 FCA.Response@Smiths-medical.com. For further questions, please call (651) 633-2556.
Quantity in Commerce 33
Distribution Internationally to Finland
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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