Model Numbers: 16026 Symbiq One-Channel Infuser 16027 Symbiq Two-Channel Infuser
List Number Configurations:
Use: The Symbiq Infusion System is an infusion pump 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.
Recalling Firm: Hospira, Inc. 755 Jarvis Drive Morgan Hill, CA 95037
Reason for Recall: There is potential for the device to fail to detect air in line at the end of an infusion.
Public Contact: Questions should be directed to Hospira, Inc. at 1-800-241-4002. Monday through Friday from 9:00 a.m. to 5 p.m. Eastern Time.
FDA District: San Francisco
FDA Comments: Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira states the user does not have to remove or stop using the Symbiq infusion pump. Hospira also provided recommended mitigation actions for users. A link to the June 11, 2010, letter is provided in Useful Links below.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.