Oridion Systems Ltd. (PINK:ORDNF) can resume importing medical devices into the U.S., after the FDA reduced its ban on the company to include just 2 of its product lines.
On Dec. 20, 2011, the Israeli med-tech maker was barred by the FDA from importing any medical devices into the U.S, after the agency said the company failed to fix violations at its Jerusalem manufacturing facility.
Earlier this week, the company was notified by the agency that it was narrowing the ban to include just the company’s infant neonatal intubated CO2 sampling lines, specifically the Infant/Neonatal FilterLine H Set and Infant/Neonatal VitaLineTM H Set line.
Oridion officials said they were pleased that the agency had narrowed its initial actions.
"As good news as this is for Oridion this is better news for clinicians and patients," Ruth Kane, Oridion’s director of marketing, communications told MassDevice.
At the time of the import restriction, Oridion said it expected to fall short of its 2011 revenue growth guidance, reaching only 17% instead of 20%. On The Street, shares of Oridion fell 39% on news of the ban.
The FDA action came after nearly 6 months’ worth of warnings from the agency. Oridion stepped into the federal watchdog agency’s spotlight in June when an investigation was launched after Philips (NYSE:PHG) recalled 8 lots of infant and neonatal carbon dioxide sampling lines manufactured by Oridion on concerns that they may contain hair-like plastic strands that infant patients could inhale.
The med-tech maker was hit with a warning letter from the FDA in October for missing device history documentation and insufficient quality controls at its Jerusalem plant.
The FDA’s warning letter stated that if left uncorrected, the sampling lines may be subject to FDA refusal and "detention without physical examination."