Becton Dickinson (NYSE: BDX) is initiating a voluntary product recall for its 100ml Plastipak catheter tip syringes over leakage issues the company caught during testing.
The Franklin Lakes, N.J. company discovered that the devices, which are labeled with a 5-year expiration date, were found to be failing during routine real-time stability tests, beginning at the 2-year time point, according to an urgent field safety notice.
There have been no reports of adverse events related to the failure, Becton Dickinson said.
The devices are usable for 18 months after production, and BD said it is recalling lots labeled with a shelf life of 5 years.
A total of 275 lots were identified in the recall, with expiration dates beginning in Dec., 2016 and ranging to April, 2021, according to the urgent field safety notice.
BD recommended that users with the devices identify and stop using the affected lots immediately, and arrange for a replacement with the company.
The recall also affected a select number of Medtronic (NYSE:MDT) Covidien Procedure Packs which contained the affected BD Plastipak Syringes. Medtronic recommended customers with the devices not use the syringes included, but specified that the other products in the kit were safe to use.