The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning ACME Monaco Guidewire .035x150 3MMJ TCFC Item 88241[Product codes and Lot numbers: 054372-1-1A; 054372-1-1B; 054372-1-2A]. The affected products, manufactured by Medline Industries, Inc, were distributed from March 2013 through August 2013..
The ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241 is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC, item number 88241, have a potential for the coating to flake off of the wire which may result in serious adverse health consequences.
According to the FDA, affected users should examine their inventory. The affected guidewires should be removed from the kit and returned to the manufacturer. The rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply.
For details, please refer to FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387123.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm387097.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 February 2014