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FDA warns Hospira over Costa Rica infusion pump

Wednesday, August 29, 2012

Hospira said it had received a warning letter from the US Food and Drug Administration over quality problems at the Costa Rican plant that makes most of its infusion pumps.

The warning, stemming from an April inspection by US regulators, does not restrict production or product shipments from the plant in La Aurora de Heredia, Costa Rica, Hospira said.

Among the issues cited by the FDA were ongoing problems with the company's Plum brand infusion pump, which Hospira recalled in February 2011 because of problems with its alarm.

Source: Reuters