Teleflex Medical Hit with Another Class I Recall

The endobronchial tube recall is Teleflex's second Class I recall this year.

Nancy Crotti

Teleflex (TFX) Medical is recalling an endobronchial tube that might shred or break, in what FDA is classifying as a Class I recall.

The company has received customer complaints that the double swivel connector on its Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube may break or separate on the tube, according to a statement by FDA. This may cause the device to leak and the patient to not receive enough oxygen or experience respiratory distress. Such a situation could possibly lead to re-intubation, patient injury or death, FDA said.

An endobronchial tube is a plastic tube that is inserted through the mouth into the main passageway into the lungs. The tube is used during bronchospirometry, a medical procedure that determines how well a lung is working. 

Teleflex initiated the U.S. recall of 62,882 of its right-sided and left sided endobronchial tubes, their double-swivel connectors, and accessory packs on June 1. The devices were manufactured from October 2013 to April 2015 and distributed until May 2015, FDA reported.

This is the third major recall of 2015 for Teleflex, and the second designated Class I.

In June, FDA announced that Teleflex was recalling thousands of neonatal resuscitators worldwide, including 2,405 sold in the United States. FDA has termed it a Class I recall.

The disposable Hudson RCI Lifesaver neonate manual resuscitator's oxygen intake port may be blocked, which could prevent the bag from filling. Teleflex reported three complaints, but no injuries or deaths.

In February, FDA announced a Class 2 recall of nearly 16 million Aquapak humidifiers due to the presence of foreign particles in the packaging.

In February 2014, Teleflex voluntarily recalled a faulty tracheal tube in another FDA-designated Class I event. It involved Teleflex's ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet).

The recall came after complaints to the company that the tracheal tube could kink during patient use, creating a life-threatening situation. Teleflex started that recall through a letter to its U.S. customers on January 6, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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