The voluntary recall by Teleflex Medical (NYSE:TFX) of its Isis HVT tracheal tube was given Class I status by the FDA, denoting the risk of serious injury or death.
Teleflex said it issued the recall because of the potential for the tracheal tube to kink and deprive patients of ventilation, possibly leading to hypoxic injury or anoxia.
Customers were notified of the recall Jan. 6 when Teleflex sent them a letter instructing them to immediately discontinue use of the recalled devices and return unused product to the Limerick, Pa.-based medical device company, according to a press release.
Teleflex said it’s recalling product codes 5-13012 through 5-13018 and 5-14012 through 5-14018. A full list of the affected lots of the Isis HVT tubes can be found here.
In December, Teleflex closed its $263 million acquisition of medical devices maker Vidacare. The deal, announced in late October, gives Teleflex an entry into the inside-the-bone access market.