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U.S. Department of Health and Human Services

Class 2 Device Recall Symbiq

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 Class 2 Recall
Symbiq
see related information
Date Posted March 08, 2011
Recall Status1 Terminated on November 07, 2013
Recall Number Z-1596-2011
Recall Event ID 57892
Premarket Notification
510(K) Number
K051550 
Product Classification Pump, Infusion - Product Code FRN
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, California 95037-2810
For Additional Information Contact Edgar Hernandez
408-782-3585
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.
FDA Determined
Cause 2
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = EVENT MEDICAL LTD.
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