Abbott Electrophysiology recalls FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Ste…

Recall date

August 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2478-2015

FDA classification

Class III

Brand / firm

Abbott Electrophysiology

Sold / distributed

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.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.