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Pumps used to infuse medications and other fluids into critically ill pediatric patients and newborns are being recalled because a defect in the product may cause it to stop working. A delay or interruption in the therapy these products provide could cause serious injury or death in the young patients it is used on.
Symbiq Infusers, made by Hospira, are infusion pumps used to deliver fluids by parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The defect is in the motor encoder that causes it to stop working. The recall is classified by the Food and Drug Administration (FDA) as a Class 1, which is the most serious type of recall issued by the FDA and involves situations in which where there is a reasonable probability that use of these products can cause serious injury or death.
Hospira issued a recall alert and mailed an Urgent Device Field Correction notice to customers who received the defective pumps on February 22, 2010. Information regarding additional recall actions were also provided in an update Recall Notification letter on October 4, 2010. The affected pumps were distributed between December 23, 2006 and January 22, 2010.
Corrected loaner pumps will be provided to customers at no cost for critical care areas until Hospira can upgrade all Symbiq pumping mechanisms. In the interim, customers who have the recalled products are urged to consider alternate methods to administer therapy.
Any serious events experienced with the pumps should be reported to the FDA MedWatch Adverse Events Reporting Program at www.FDA.gov/Medwatch.
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