FDA Prohibits Hospira from Importing Symbiq Infusion Pumps
Hospira Inc., the Illinois-based maker of medical devices and injectable specialty drugs, is barred by the Food and Drug Administration (FDA) from importing into the U.S. its Symbiq infusion pumps, which are manufactured at its Costa Rica plant.
Reuters reports that the company shared the information in a regulatory filing that did not explain why the FDA took the action. The restriction, however, does not include import of other medical management products made by the company.
Hospira issued a voluntary hold on shipments of Symbiq infusion pumps from the plant on Nov. 7, a day before the FDA imposed the restriction, according to its 8-K filing. The company promised to provide its customers with support in repair and replacement of the defective pumps.
Reuters writes that last month the company received some reports of the touch screens on the Symbiq infusion pumps becoming unresponsive, leading it to recall of some of the infusion pump models, according to the FDA. The software issue with the touch screens of the pumps caused a delay in therapy administration to patients in need of prompt and timely help.
In August, Hospira received a warning letter from the FDA over quality issues at its Costa Rica plant. Failure of the alarm system used in Hospira’s Plum brand of infusion pumps was cited in the letter. A spokesperson for the company said at the time that it was switching alarm components for the pump and expected to complete that process by early next year.