Reported Oct 9, 2013 · Terminated
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis ADROIT 6F
- Guiding Catheter Product UsageFor intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system
- Lot codes and dates
- Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737,15892738, 15892739 67205400 15885645, 15887472,
15897416672005001590131467203400159220216720360015897418672040001592568767205200
15887473, 15887474,15897420672056001590131967206000158974226720720015892740672080001589274167208200
158974246720830015901321672126001591694267213000159169436722700015901323
- Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737,
- Amount recalled
- 1238 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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