Acme Recalls Monaco Guidewire Due to Coating Flaking Off

 

March 4, 2014

March 4, 2014 — The U.S. Food and Drug Administration (FDA) has sent out a Class 1 recall notice regarding various convenience kits containing Acme Monaco Guidewire 0.035 x 150 3 MMJ TCFC, item number 88241.

The recalled item has a potential for the coating to flake off of the wire, and its use 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 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.

The FDA recommends that 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 through the following:

  • Completing and submitting the report online at: www.fda.gov/MedWatch/report.htm
  • Downloading the form or calling (800) 332-1088 to request a reporting form, then completing and returning to the address on the pre-addressed form. The form can also be submitted by fax to (800) FDA-0178.


For more information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387123.htm

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