Agency classClass IIOur severity:Severe FDA (Devices)·Z-2202-2018·Announced 2018-06-20

Angiodynamics Recalls Bioflo Midline Catheters Due to Bacterial Endotoxins

Angiodynamics Inc. is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters 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 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 agency classified this as a Class II recall. The presence of unsafe levels of bacterial endotoxins in a medical device poses a significant risk of adverse health consequences, fitting the 'Severe' criteria for significant injury risk or high-risk contamination.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 3 boxes of RS - TANDEM 5F DL BIOFLO MIDLINE catheters, Catalog Number 60M035472. 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 5312194, and the Universal Product Number (UPN) is H96560M0354721.

Healthcare providers and consumers should stop using these specific devices and contact the recalling firm for further instructions or a replacement.

The recalled product

Product: RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — Catheters
Hazard: bacterial-endotoxins
pyrogens
Affected units: 3

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: H96560M0354721
Lot: 5312194

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 endotoxins