Hospira is recalling its Symbiq Infusion Systems One-Channel and Two-Channel Infusers, the U.S. Food and Drug Administration (FDA) announced last week. The recall is a Class I, the agencyâ€™s most serious.
The Symbiq One-Channel and Two-Channel Infuser System is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes.
This recall has been implemented because of the potential for the device to fail to detect air in line at the end of an infusion. Failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death.
Hospira mailed clinical bulletins to affected customers on April 9, 2010, and also issued an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira stated tat the user does not have to remove or stop using the Symbiq infusion pump, and also provided recommended mitigation actions.
In the FDAâ€™s announcement, it noted that healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1-800-332-1088 to request a reporting form, then complete and submit the report online here. Complete and return the form to the address on the pre-addressed form; or complete and submit the form by fax to 1-800-FDA-0178.