FDAClass IIApril 20, 2016

USE (Ebony) PTA .014" rapid exchange (RX) Peripheral recall

USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.

Why was USE (Ebony) PTA .014" rapid exchange (RX) Peripheral recalled?

Product may kink during use rendering the product unusable.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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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Product
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Recalling firm
Us Endovascular
Quantity
843 catheters
Distribution
US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
Recall date
April 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls