USFDA CDRH Medical Device Recall Alert : Teleflex Medical, Hudson RCI Pediatric Anesthesia Breathing Circuits - Circuit Ends May Crack or Break

Hudson RCI Pediatric Anesthesia Breathing Circuits

Recall Class: Class 

Date Recall Initiated: September 8, 2014

Devices: Hudson RCI Pediatric Anesthesia Breathing Circuits.  

See complete listing of recalled devices

• Manufacturing Dates: March 2013 to July 2014
• Distribution Dates: June 2013 to May 2014

Use: Anesthesia circuits deliver a mixture of anesthesia and/or other gases from a mechanical ventilator to a patient. This device is used in hospitals to care for pediatric patients.

Recalling Firm:
Teleflex Medical, 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Reason for Recall:

The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately.

Use of this device may also cause death.

Public Contact: For questions about this recall, contact the firm’s Customer Service at cs@teleflex.com or 1-866-246-6990, Monday - Friday, 8:00 a.m. - 7:00 p.m., Eastern Time, or call your local sales representative.