FDA-Device2013-10-09Class IIMISBRANDING
Cordis ADROIT 6F Guiding Catheter recalled for metric conversion labeling error
LABEL MIX UPNationwide distribution
Check Cordis ADROIT 6F catheter lot numbers
Cordis Corporation identified a labeling error on certain ADROIT 6F Guiding Catheters where the inner diameter measurement was incorrectly converted from inches to millimeters. The English dimension on the label is correct; the metric conversion is wrong. This affects specific lot numbers distributed in the USA and several other countries.
- Check your catheter lot number against the list provided by Cordis
- Contact Cordis or your supplier if you have an affected lot
- Refer to the English dimension (inches) as the accurate specification when using affected units
Hazard
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Sold states
Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
Affected count
1238 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2014Don't want to check this manually?
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