The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0418-2021·Announced 2020-11-11

Angiodynamics 5F Micro-Introducer Kits Recalled for Incorrect Device Packaging

Angiodynamics, Inc. is recalling 32 kits of 5F Standard Micro-Introducer Kits because they may contain a 4F Sheath/Dilator component instead of the correct device.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a packaging error where the wrong device component is included. No injuries or illnesses are reported in the source text, and the hazard is a potential procedural error rather than a direct toxic or structural failure.

Plain-English summary

Angiodynamics, Inc. is recalling 32 kits of the 5F Standard Micro-Introducer Kit (Catalog Number: 06597035, Lot Number: 5626935, Expiration Date: 08/31/2023). The recall is due to a packaging error where the kits may contain a 4F Sheath/Dilator component instead of the correct device. The product is indicated for the percutaneous introduction of a guidewire or catheter into the vascular system.

The affected products were distributed nationwide in the United States, including in the states of Alabama, Connecticut, Georgia, and Florida. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare facilities and distributors should stop using the affected kits and contact Angiodynamics, Inc. for instructions on return or replacement. Patients who have received the affected product should contact their healthcare provider for evaluation.

The recalled product

Product
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Catheters
Hazard
Affected units
32

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 (1)

  • Lot Number: 5626935 Expiration Date: 08/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same manufacturer · Angiodynamics, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls