Reported Jun 5, 2013 · Terminated
AngioDynamics Micro Introducer Kits 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 Micro Introducer Kits under the following labeling
5 of 5 products
| Model / number | Product as published |
|---|---|
06597005 | AngioDynamics 4F Standard Micro-Introducer Kit, Sterile |
06597012 | AngioDynamics 5F Standard Micro-Introducer Kit, Sterile |
06597013 | AngioDynamics 4F Standard Micro-Introducer Kit, Sterile |
06597018 | AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, ; and |
06597019. | AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Product kits are individually wrapped in plastic, 10 units included per box. 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 numbers1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016)
- Amount recalled
- Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
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 incorrect French size.
This product could cause temporary or reversible health problems — stop using it.
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