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U.S. Department of Health and Human Services

Class 2 Device Recall Level 1

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  Class 2 Device Recall Level 1 see related information
Date Initiated by Firm November 07, 2006
Date Posted December 06, 2006
Recall Status1 Terminated 3 on November 30, 2009
Recall Number Z-0250-2007
Recall Event ID 36758
510(K)Number BK860023  
Product Classification I.V. Fluid Administration Set - Product Code FPA
Product Level 1¿ Normothermic I.V. Fluid Administration Set
REF D-60HL
Code Information Lot numbers: 1009446, 1035977, 1043174, 1046075, 1048466, 1060983
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information Contact Timothy Talcott
603-352-3812 Ext. 2457
Manufacturer Reason
for Recall
IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
FDA Determined
Cause 2
Equipment maintenance
Action Smiths Medical ASD notified Direct customers and distributors via letter sent by UPS on or about November 6, 2006 and the days following as necessary until all consignees are notified. Letters to direct customers will be addressed to the Risk Manager. All Smiths Medical affiliates contacted by e-mail and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product. US Distributors instructed to return the affected product and to provide a customer list. Foreign distributors instructed to return the affected product and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product.
Quantity in Commerce 1480 units
Distribution Worldwide, including USA, Japan, Canada, Ireland, UK, Finland, Netherlands, Germany, Austria, Portugal, France, Sweden, Australia, New Zealand, Russia, Italy, Singapore, Kuwait, Saudi Arabia, Czech Republic, Dubai, Spain, Norway, Denmark, and East Temor.
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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