FDA MedWatch - Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage

Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage

AUDIENCE: Risk Manager, Emergency Medicine, Critical Care Medicine, Pediatrics

ISSUE: The oxygen intake port may be blocked which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.

BACKGROUND: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device used to provide temporary breathing support for patients during periods of acute ventilatory failure.

RECOMMENDATION: On May 14, 2015, Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product. Customers are asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. The letter also requested a sub-recall of the product through the distributers instructing them to immediately discontinue distribution and quarantine the recalled products, and notify their customers who have received the product of the recall.

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453586.htm