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.
FDA Recall Z-1847-2013 · Posted 2013-08-01
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-02-04
Date Terminated2016-11-07
Product Quantity2,791 units
Reason for Recall
The devices secondary audio signal fails to activate.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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