Z-1362-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2016
- Initiation Date
- February 11, 2016
- Termination Date
- November 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 843 catheters
Product Description
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Reason for Recall
Product may kink during use rendering the product unusable.
Distribution Pattern
US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
Code Information
All references USE .014RX. Lot numbers: 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164730 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164760 1717101610166240 1717082810164760 1717082810164770 1717082810164770 1717101610166260 1717101610169180 1717101610169180 1717101610169180 1717101610166260 1717101610169180 1717101610166260 1717082810164770 1717101610166260 1718041510177220 1717082810164770 1717101610169180 1717082810164780 1717101610166270 1717082810164780 1717101610166270 1717101610166270 1717101610169190 1717082810164800 1717101610169190 1717101610169190 1717101610169190 1717101610166280 1717082810164810 1717082810164810 1717101610166290 1717082810164810 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