ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off

[Posted 02/25/2014]

AUDIENCE: Risk Manager

ISSUE: 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. 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

BACKGROUND: An 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 Industries, Inc. The affected products were distributed from March 2013 through August 2013.

RECOMMENDATION: Customers should examine their inventory. The affected guidewires should be removed from the kit and returned to Medline. The rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/25/2014 - Recall Notice - FDA]