The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning sterile convenience surgical packs [Manufacturing Dates: January 9, 2009 to May 19, 2014; Distribution Dates: January 2009 to May 2014], manufactured by Customed, Inc.
According to the FDA, on 3 June, 2014, the manufacturer initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. Users who have the products are advised to stop using the affected product lots.
For details, please refer to the following FDA website:
http://www.fda.gov/Safety/Recalls/ucm411442.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Aug 2014