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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer

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 Class 2 Device Recall Smiths Medical HOTLINE 3 Blood and Fluid Warmersee related information
Date Initiated by FirmJune 27, 2012
Date PostedJuly 09, 2012
Recall Status1 Terminated 3 on February 20, 2014
Recall NumberZ-1979-2012
Recall Event ID 62389
510(K)NumberK911383 
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
ProductSmiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
Code Information All serial numbers
FEI Number 1221261
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information Contact
781-878-8011
Manufacturer Reason
for Recall		 HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable
FDA Determined
Cause 2		Device Design
ActionSmiths Medical sent an Urgent Medical Device Correction -Field Safety Notice letter dated June 21, 2012 via U.S. Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter included an Urgent Medical Device Field Safety Notice Acknowledgement Form ("Confirmation Form") that customers were instructed to complete and return to Smiths Medical for carrying out the correction and affectivity tracking purposes. The letter stated that a Smiths Medical Representative will visit the affected sites to correct the units with a shelf upgrade kit, which includes instructions and all the parts necessary to make the correction to their affected devices. Customers were provided with a form to record the serial numbers of the devices corrected so that this can be returned to Smiths Medical. For questions regarding this information call Smiths Medical Quality Department at 1-781-763-9335. .
Quantity in Commerce2247 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LGZ
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