Agency classClass IIOur severity:High FDA (Devices)·Z-1346-2016·Announced 2016-04-13

AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

AngioDynamics is recalling 45 NAMIC Convenience Kits because the needle inner lumen may be too small to accept a 0.038-inch guidewire.

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 defect that prevents the intended use of the product (inability to accept a guidewire), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

AngioDynamics Inc. is recalling 45 units of the NAMIC Convenience Kit Mercy General Hospital Neuro Kit (Catalog No. 601319810, UPN Product No. H7496013198101). The recall was initiated because the inner lumen of the needles in the affected lots did not meet the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038-inch guidewire as intended, with some inner lumens found to be 0.036 inches.

The affected products are identified by Batch/Lot Nos. 4931728 and 4933094, with a Use By date of 2017-03. These kits were distributed nationwide in the states of California, Illinois, Massachusetts, South Carolina, and Texas. The needle is intended to be placed over the guidewire to enlarge the opening in the vessel and is removed before sliding the catheter over the guidewire.

Healthcare facilities and consumers should stop using these specific kits and contact AngioDynamics Inc. for further instructions or a return.

The recalled product

Product: NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter…
Manufacturer: AngioDynamics Inc.
Category: Medical Device — Neurovascular Kits
Hazard: device-defect
inability-to-use
Affected units: 45

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 (3)

Batch/Lot No. 4931728
4933094
Use By 2017-03

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · AngioDynamics Inc.

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