Hospira, an infusion pump manufacturer based in Lake Forest, Illinois, faces an import ban on its Symbiq infusion pumps. The import ban, issued by the United States Food and Drug Administration (FDA), will prohibit the sale of Symbiq infusion pumps manufactured in the company’s Costa Rica facility.

In October of last month, the company faced a Class I recall on its Symbiq infusion pumps due to a touchscreen issue. According to the FDA, the touchscreen issue may lead to improper data entries. This can result in over- or under-medication. In addition, the touchscreen issue may result in delayed delivery of medication. Both of these issues have the potential to kill or injure patients.

Several days ago, the company issued a voluntary hold on shipments of its Symbiq infusion pump from Costa Rica. The hold applies to the company’s 16027 Symbiq Two Channel Infusers and 16026 Symbiq One Channel Infusers.

The FDA initially warned that, "the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response or may register a different value from the value selected by the user."

References

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...