Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cordis Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Product Codes/Lot Numbers:
Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0003-2014
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