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U.S. Department of Health and Human Services

Class 2 Device Recall Symbiq

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 Class 2 Device Recall Symbiqsee related information
Date Initiated by FirmOctober 27, 2010
Date PostedMarch 08, 2011
Recall Status1 Terminated 3 on November 07, 2013
Recall NumberZ-1596-2011
Recall Event ID 57892
510(K)NumberK051550 
Product Classification infusion pump power cord - Product Code FRN
ProductHospira 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.
FEI Number 2921482
Recalling Firm/
Manufacturer		 Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information ContactEdgar 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		Component design/selection
ActionHospira Recall notification letters were sent by Federal Express on November 1, 2010.
Quantity in Commerce32,376 power cords
DistributionNationwide distribution and to Australia, Canada, and Malaysia.
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 = FRN
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