FDA recall Z-1198-2019

Cordis Corporation · Class III · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-02-07
Report date
2019-04-24
Termination date
2021-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2019