Home > FDA MedWatch > FDA MedWatch – Davol XenMatrix Surgical Graft: Class I Recall

FDA MedWatch – Davol XenMatrix Surgical Graft: Class I Recall

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.

CLICK HERE to read the MedWatch safety alert, including a link to the Class I Recall notice.

Advertisements
  1. No comments yet.
  1. No trackbacks yet.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s

%d bloggers like this: