  |
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use
AUDIENCE: Critical Care Medicine, Risk Manager, Emergency Medicine
ISSUE: The cuff inflation line of certain KimVent Microcuff Endotracheal tubes may detach from the tube during use (if pulled, tugged, or excess tube/patient movement occurs). If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
This recall affects device manufacturing dates November 15, 2013 to October 21, 2014, and distribution dates December 20, 2013 to October 30, 2014.
BACKGROUND: The firm received 19 reports where the device malfunctioned. In most cases the problem was identified immediately, while in other cases, it was identified when ventilator alarms went off. Most patients required reinsertion of endotracheal tubes.
RECOMMENDATION: On November 17, 2014, Halyard Health sent customers an Urgent Voluntary Product Recall. The letter described the product, problem, and actions to be taken. Customers who have this product in their inventory should stop using all unused recalled devices and quarantine them. See the recall notice for additional information, or call Halyard Regulatory Affairs at 770-587-7400 for questions about this recall.
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
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
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 kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
