AngioDynamics Recalls VenaCure EVLT NeverTouch Procedure Kits Due to Sizing Error
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where the specific injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AngioDynamics Inc. is recalling VenaCure EVLT NeverTouch Procedure Kits and Micro Introducer Kits. The recall is issued because there is a potential that the micro Introducer (sheath/dilator) packaged within the kits could be the wrong French size.
The affected products include the Gold-Tipped Fiber 45cm Kit (Catalog Number: 11403301), Gold-Tipped Fiber 65cm Kit (Catalog Number: 11403302), and Gold-Tipped Fiber 90cm Kit (Catalog Number: 11403304). The corresponding lot numbers are 588948, 588495, and 588480, with an expiration date of 12/2013. The recall covers domestic distribution in the United States, including specific states such as Illinois, Georgia, California, New York, Ohio, Arizona, Texas, Nebraska, Florida, Pennsylvania, North Carolina, Wisconsin, Alabama, Indiana, Colorado, Missouri, Montana, Massachusetts, Virginia, Alaska, Michigan, New Jersey, Maryland, Tennessee, Connecticut, and Washington.
Healthcare providers and consumers should stop using these kits and contact AngioDynamics Inc. for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product…
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Surgical Kits
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Corresponding Lot numbers: 1) 588948
- 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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