  |
Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break
AUDIENCE: Risk Manager, Pediatrics, Anesthesiology
ISSUE: The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
Manufacturing Dates: March 2013 to July 2014
Distribution Dates: June 2013 to May 2014
BACKGROUND: 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.
RECOMMENDATION: On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. See complete list of recalled devices.
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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
