The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1405-2013·Announced 2013-06-05

AngioDynamics Recalls Micro Introducer Kits Due to Potential Size Mismatch

AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect 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 involves a medical device where a component size mismatch could lead to improper use or injury, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

AngioDynamics Inc. is recalling specific lots of Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits. The recall is issued because there is a potential that the micro introducer (sheath/dilator) packaged within the kit could be the incorrect French size.

The affected products include five specific catalog numbers of AngioDynamics Standard Micro-Introducer Kits, which are individually wrapped in plastic with 10 units per box. The source text notes that the device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. The recall covers 1,760 domestic units and 10 foreign units distributed nationwide in the United States.

Healthcare providers and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority for further instructions.

The recalled product

Product
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard…
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Interventional Cardiology / Vascular
Hazard

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 (4)

  • Corresponding Lot numbers: 1) 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).

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

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.

See all 2 products in this recall →

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