Agency classClass IIOur severity:Severe FDA (Devices)·Z-1467-2021·Announced 2021-04-28

AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk (compromised sterility) falls under the 'Severe' category (Score 4), particularly given the potential for serious injury from infection.

Plain-English summary

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Safe Sheath Ultralite Vascular Introducer/Catheter Introducer kits (Catalogue #: VI10, Lot #: DP-11759). The recall is being conducted because the devices may have a potential for compromised sterility. The product is used for the introduction of various types of pacing leads and catheters.

The recall involves 337 units, consisting of 14 boxes of 5 and 267 units per kit. These products were distributed nationwide in the United States, specifically in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, and WA. No other products or lots are affected by this recall action.

Healthcare facilities and consumers should stop using the affected products and contact AngioDynamics for further instructions or a return.

The recalled product

Product: AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — Vascular Access
Hazard: sterility-compromise
infection-risk

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)

UPN: VI10
Lot #: DP-11759

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Angiodynamics Inc. (Navilyst Medical 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 →

Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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Same hazard · sterility compromise