Cordis Corporation recalls Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravas…

Recall date

February 7, 2019

Source

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

Recall number

Z-1198-2019

FDA classification

Class III

Brand / firm

Cordis Corporation

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada

Why it was recalled

Frayed pieces of the mounting card being inside the primary packaging.

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

What was recalled

Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.