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Class 2 Device Recall Symbiq |
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Date Initiated by Firm |
October 27, 2010 |
Date Posted |
March 08, 2011 |
Recall Status1 |
Terminated 3 on November 07, 2013 |
Recall Number |
Z-1596-2011 |
Recall Event ID |
57892 |
510(K)Number |
K051550
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Product Classification |
infusion pump power cord - Product Code FRN
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Product |
Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser |
Code Information |
Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser List number configurations: 16026-04-01/03/04, 51/52,. 53/54, 79/80, 81/82, 83/84/ 87/88; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88; 16026-13-25/26, 53/54; 16027-13-25/26, 53/54. |
Recalling Firm/ Manufacturer |
Hospira Inc 755 Jarvis Dr Morgan Hill CA 95037-2810
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For Additional Information Contact |
Edgar Hernandez 408-782-3585
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Manufacturer Reason for Recall |
Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on Symbiq AC Power cords.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Hospira Recall notification letters were sent by Federal Express on November 1, 2010. |
Quantity in Commerce |
32,376 power cords |
Distribution |
Nationwide distribution and to Australia, Canada, and Malaysia. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = EVENT MEDICAL LTD.
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