Teleflex Recalls Hudson Manual Resuscitator
Wayne, Pa.-based Teleflex has initiated a voluntarily recall of its Hudson RCI Lifesaver neonate manual resuscitator, the company said Monday.
The FDA labeled the recall a Class I, indicating there is a risk of serious injury or death when using the product.
In a May 14 letter to customers, the company says the device might have a blocked intake port which could cause the bag not to fill. Teleflex claims there have no reports of patient injury, but notes a delay in treatment could occur, with the potential to cause adverse events such as an oxygen deficiency.
The lots affected are listed on the company’s website. Read the devicemaker’s recall notice at www.fdanews.com/TeleflexRecall07-02-15.pdf. — Jason Scott