Healthcare giant Baxter (NYSE:BAX) recalled 2 lots of its Dual Luer Lock Caps after finding "particular matter" loose in the devices’ packaging, the company announced last week. The measure got the FDA’s highest-risk Class I label.
The caps are used as protective locks to protect access ports on certain medical devices, such as IVs, when they’re not in use. Loose particles creeping into such ports could result in thrombotic or embolic events, including strokes or heart attacks, Baxter said.
There have been no reports of any adverse events, the company reported, but the measure nonetheless got the FDA’s Class I label, reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The affected caps were distributed between June 19, 2013, and August 20, 2013, according to the FDA report. Customers were advised not to use any products from the affected lots and to return them to Baxter for credit.
The financial impact of the recalls was not material, Baxter said.