The FDA issued a Class I recall for ACME Monaco Guidewire .035x150 3MMJ TCFC, item number 88241, manufactured by Medline Industries, Inc.
Various convenience kits containing this guidewire have a potential for the coating to flake off of the wire. Use of this recalled product may result in serious adverse health consequences.
Product codes included in this recall are 054372-1-1A, 054372-1-1B, and 054372-1-2A.
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. This guidewire is used in various surgical convenience kits assembled and marketed by Medline. The affected products were distributed from March 2013 through August 2013.
The affected guidewires should be removed from the surgical kits and returned to Medline.
See the FDA Safety Announcement