Agency classClass IIOur severity:High FDA (Devices)·Z-1344-2016·Announced 2016-04-13

AngioDynamics Recalls Renown Regional Medical Center Convenience Kits

AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended 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 where the product fails to perform its intended function (accepting the guidewire), creating a risk of harm during a procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

AngioDynamics Inc. is recalling 100 units of the NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER (Catalog No. 65230029). The affected products are identified by Batch/Lot Nos. 4925152 and 4930012, with a Use By date of 2018-08. The kits were distributed nationwide in California, Illinois, Massachusetts, South Carolina, and Texas.

The recall was initiated because the inner lumen of the needles in the affected lots does 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 measuring 0.036 inches. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel before sliding the catheter over the guidewire.

Healthcare providers and facilities that have received these products should stop using them and contact AngioDynamics Inc. for further instructions on the recall.

The recalled product

Product: NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to…
Manufacturer: AngioDynamics Inc.
Category: Medical Device — Interventional Cardiology
Hazard: device-defect
procedural-failure
Affected units: 100

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. 4925152
4930012
Use By 2018-08

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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