FDA issues another Class 1 recall for Teleflex

The FDA has issued a recall on Teleflex‘s (NYSE:TFX) Hudson RCI Sheridan Sher-I-Bronch endobronchial tube due to issues with the connector cracking or separating

The FDA has labeled the recall as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Teleflex has received customer complaints about the tube’s double-swivel connector breaking or separating from the tube, the FDA said. Such a break can cause device leakage, in turn causing the patient not to receive enough oxygen, and could lead to the need to re-intubate and possible injury or death, the federal watchdog stated.

A total of 62,882 devices in the U.S. are affected by the recall, manufactured between October 2013 and April 2015 and distributed between October 2013 and May 2015.

Teleflex began sending letters to affected customers in June, instructing them to stop use and quarantine any remaining products. A complete listing of the lot numbers was posted in the FDA filing.

The recall is the 3rd in a series of recalls related to Teleflex’s Hudson RCI tubes. In July, Teleflex recalled 2,045 Hudson RCI Lifesaver single patient use manual resuscitators in a Class I recall over issues with intake oxygen port blockage.

In late June, Teleflex saw another Class I recall for its Hudson RCI Lifesaver neonate manual resuscitator, due to similar intake issues and blockages that could cause fatal injuries. The recall affected 9,333 units.

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