Recall Class: Class I
Date Recall Initiated: August 14, 2013
Product: ACME Monaco Guidewire .035x150 3MMJ TCFC item 88241
The affected products were distributed from March 2013 through August 2013.
Product Codes and Lot Numbers:
Use: 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.
Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan, Illinois 60085
Reason for Recall: Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC item number 88241 has a potential for the coating to flake off of the wire. Use of this recalled product may result in serious adverse health consequences.
Public Contact: For questions about this recall, customers may contact Medline Industries at 1-886-359-1704.
FDA District: Chicago District Office
FDA Comments: On August 14, 2013, Medline Industries, Inc. sent Recall Notification letters to inform customers of the problem. Customers should examine their inventory, affix a provided sticker on the affected kits warning users that the Acme Monaco Guidewire .035X150 3MMJ TCFC item number 88241 has been recalled and should not be used. 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. If additional stickers are needed, please call 1-866-359-1704.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.