Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devi
FDA device recall Z-0003-2014 · posted 2013-10-01 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- Cordis sent an Urgent Medical Device Recall letter dated August 12, 2013 Acknowledgement Form to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected product in a manner that ensures the product will not be used. Customers were asked to review, complete, sign and return the enclosed Acknowledgement form directly to Cordis to the fax number on the form. For questions call the Customer Service number at 800-561-7683.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 1238 units
- Distribution
- 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,
- Date initiated
- 2013-08-12
- Date posted
- 2013-10-01
- Date terminated
- 2014-09-30
- Location
- Miami Lakes, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADROIT GUIDING CATHETER (K131225) | Cordis Corp., A Johnson & Johnson Co. | 2013-05-29 |