Reported Jun 5, 2013 · Terminated
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling
Angiodynamics, Inc.
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: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling
3 of 3 products
| Model / number | Product as published |
|---|---|
11403301 | Gold-Tipped Fiber 45cm Kit |
11403302 | Gold-Tipped Fiber 65cm Kit |
11403304. | Gold-Tipped Fiber 90cm Kit, Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. |
- Lot codes and dates
- Corresponding Lot numbers
1) 5889482) 588495 and 3)588480
- Expiration date for these lot numbers12/2013
- Corresponding Lot numbers
- Amount recalled
- Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.
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
Why it was recalled
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.
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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