Reported Jun 22, 2016 · Terminated
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
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 PRECISE (R) RX Nitinol Stent System (Biliary)
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published P05030RXBLot Number: 17241836 P09030RXBLot Number: 17241838 P07030RXBLot Number : 17291878 P07040RXBLot Number: 17291879 P06040RXBLot Number: 17415243. - Amount recalled
- 4,400 units in US; 3,100 units to Foreign Countries
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Inability to deploy the stent or partial stent deployment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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