Agency classClass IIOur severity:High FDA (Devices)·Z-2194-2018·Announced 2018-06-20

Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

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 with a potential contamination hazard (bacterial endotoxins) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 246 boxes of Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887. The recall is being conducted because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

The affected products were distributed to 34 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5305574 and the Universal Product Number (UPN) is H965458870.

Healthcare providers and facilities should check their inventory for this specific catalog number and lot. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received this device should contact their healthcare provider for guidance.

The recalled product

Product: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — Interventional Radiology Kit
Hazard: bacterial-endotoxin
pyrogen
Affected units: 246

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: H965458870
Lot: 5305574

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 38 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 38 products in this recall →

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

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Same hazard · bacterial endotoxin