Israel's Oridion can breathe a little easier this week after the FDA narrowed the scope of an import alert it had imposed on the company. The agency had issued the alert last month over concerns that particulate matter may be found in the company's single-unit packaged CO2 sampling lines. The source of the particulates originated from the paper insert, warning label and banding tape inside the package, according to the company.
The import alert now only applies to infant neonatal intubated CO2 sampling lines, which will remain unavailable in the U.S. The company has resumed shipments of all other products, including CO2 sampling lines, modules and patient monitors.
When the import alert was announced, the company said its overall revenue growth for 2011 would be approximately 17%--short of the 20% guidance. It couldn't predict what effect the FDA's actions would have on sales for this year, however.
Oridion may continue to face scrutiny. It came under the agency's microscope last year after Philips Healthcare ($PHG) recalled 8 lots of infant and neonatal CO2 sampling lines the company had manufactured. There were concerns the lines may have contained small plastic strands infants could inhale, as MassDevice notes. Subsequently, Oridion was slammed with an FDA warning letter for missing documentation and insufficient quality controls at its Jerusalem plant.
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