Agency classClass IIOur severity:High FDA (Devices)·Z-2199-2018·Announced 2018-06-20

Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component 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' criteria for risk-of-harm products without reported injury.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 23 boxes of BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810. The recall was initiated 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 5314926 and the Universal Product Number (UPN) is H965468100.

Healthcare providers and consumers 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 the distributor from which it was purchased.

The recalled product

Product: BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — Vascular Access
Hazard: bacterial-endotoxin
Affected units: 23

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: H965468100
Lot: 5314926

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