FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

Reason: The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

Code information: Model number : USAR064060; Lot code: TPR031615-01

Distribution pattern: US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.