Recall Class: Class I
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.
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 email@example.com or 1-866-246-6990, Monday - Friday, 8:00 a.m. - 7:00 p.m., Eastern Time, or call your local sales representative.
FDA District: Atlanta District Office
More Information about this Recall:
On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. Teleflex Medical recommends the following actions:
- Stop using the devices.
- Remove the devices from inventory and stop distribution.
- Return the Recall Acknowledgement Form included with the letter.
- Notify any customers who may have received the devices through re-distribution.
About Class I Recalls
Class I recalls are the most serious type of recall. They involve situations when it is likely that use of these devices will cause serious health problems or death.
Health care professionals and consumers can report bad reactions or quality problems they had using the device to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.