Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includi…

Recall date

October 21, 2019

Source

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

Recall number

Z-0430-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, M…

Why it was recalled

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.