Reported Mar 23, 2016 · Terminated
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel…
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 AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
- Lot codes and dates
- Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580
- Expiration date2018-07-31
- Amount recalled
- 1,985 units
Where it was sold
Why it was recalled
Incorrect cannula of the sheath introducer (smaller than intended).
This product could cause temporary or reversible health problems — stop using it.
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