With the $346 million acquisition of Israeli device maker Oridion Systems ($ORIDN) that Covidien ($COV) announced today, it is getting a company still operating under an FDA import restriction tied to GMP concerns.
The all-cash deal was announced today, and Dublin-based Covidien, which also makes medical devices, expects the deal to close by June 30, Bloomberg reports.
The FDA in December banned the medical device-maker from importing any products into the U.S. The agency eased that considerably a month later to just two of the lines. But the ban hit the company's share price hard, and it revised its revenue expectations down several points in response, MassDevice pointed out at the time.
The regulatory spotlight hit Oridion after the recall of 8 lots of infant and neonatal carbon dioxide sampling lines because they could contain hair-like plastic strands that infant users might inhale. An inspection at its Jerusalem plant found issues. When those did not get addressed fast enough, the FDA issued a warning letter and then moved to the ban.
The company jumped into action and managed to satisfy most of the FDA's concerns a month later. The company resumed shipments of nearly all of its products, including CO2 sampling lines, modules and patient monitors. The import alert now only applies to infant neonatal intubated CO2 sampling lines, which remain unavailable in the U.S.
- here's the Bloomberg article
- get the MassDevice story