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U.S. Department of Health and Human Services

Class 2 Device Recall 1) Symbiq One Channel Infuser, 2) Symbiq Two Channel Infuser

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 Class 2 Device Recall 1) Symbiq One Channel Infuser, 2) Symbiq Two Channel Infuser see related information
Date Posted August 01, 2013
Recall Status1 Open
Recall Number Z-1847-2013
Recall Event ID 65610
510(K)Number K110901 
Product Classification Pump, infusion - Product Code FRN
Product The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

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Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
224-212-2000
For Additional Information Contact Mr. Chris Eustace
224-212-2000
Manufacturer Reason
for Recall
The devices secondary audio signal fails to activate.
FDA Determined
Cause 2
Process control
Action Hospira sent a Urgent Device Field Correction letter dated February 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In addition, letters were sent by e-mail to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites February 5, 2013. The letter was also posted on the Hospira website February 4, 2013. Customers were requested to return a reply form indicating they have received the letter and notified their users. For further inquiries please contact Hospira Global Complaint Management at 1-800-441-4100 ( 8am - 5pm CST, M-F) to report adverse events or product complaints, or Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 for additional information or technical assistance. ( 24hrs a day / 7 days a week.
Quantity in Commerce 2,791 units
Distribution US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA.
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 = HOSPIRA, INC.
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