|[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]|
AUDIENCE: Risk Manager, Surgery
ISSUE: FDA notified healthcare professionals that several lots of XenMatrix Surgical Graft have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal. This product was manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010. See the Recall Notice for a listing of specific lots affected by this recall.
BACKGROUND: This product is used in hernia and abdominal wall repair.
RECOMMENDATION: Customers should contact Davol Customer Service for instructions on how to return the products.
Read the MedWatch safety alert, including a link to the Class I Recall notice, at:
Tell us how we are doing:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter
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 e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420