A Serious Resuscitator Recall Is Underway: Here's What Happened

Teleflex says a disposable resuscitator for infants and children has issues when it comes to the bag filling.

Nancy Crotti

Teleflex Inc. is recalling thousands of neonatal resuscitators worldwide, including 2405 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. The Research Triangle Park, NC-based company reported three complaints, but no injuries or deaths.

"A delay in treatment may occur while another resuscitator is obtained," the company said in a statement. "A delay in treatment may potentially lead to adverse consequences such as hypoxia," or oxygen deficiency.

FDA reported that 9333 of the resuscitators have been distributed worldwide. Teleflex, which manufactured and sold them between June 2014 and April 2015, is recalling unused units.

This is the second major recall for Teleflex this year. In February, FDA announced a Class 2 recall of nearly 16 million Aquapak humidifiers due to the presence of foreign particles in the packaging.

Because of the life-and-death situations in which they are used, recalls can be serious with resuscitators.

Last year, FDA and Ventlab LLC announced that Ventlab was recalling manual resuscitator bags because a duckbill valve may stick and prevent air from getting to the patient.

At the time, one injury had been reported due to a stuck valve, which can prevent oxygen from reaching tissues--slowing breathing and even leading to death. The company received 31 reports of a delay in oxygenation. FDA designated it a Class I recall.

Also in 2014, GE announced a recall of a host of infant resuscitators from the past five years over a serious error during the assembly process.

Nancy Crotti is a contributor to Qmed and MPMN.

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