Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1087-2017·Announced 2017-02-01

Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging

Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.

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, which typically indicates a reasonable probability that use of the product may cause temporary or medically reversible health consequences. The specific defect is non-sterile outer packaging, which is a labeling/packaging issue rather than a direct structural defect or reported injury.

Plain-English summary

Atrium Medical Corporation is recalling its 400 Series Express Drains, including specific models such as the Express single collection drain, PreFilled Chest Drain, dual chamber drain, and Blood Recovery drain. The recall is being conducted because the outer packaging of these devices is not sterile.

The affected products are intended to evacuate air and/or fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate postoperative collection and reinfusion of autologous blood. The recall covers all lot numbers with expiration dates prior to October 2019.

A total of 964,463 cases were distributed in the United States and 521,975 cases were distributed outside the US, totaling 1,486,438 cases. The products were distributed nationwide in the US and in numerous countries worldwide, including Australia, Brazil, Canada, China, France, Germany, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Atrium Medical for further instructions.

The recalled product

Product: Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery…
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical Drains
Hazard: non-sterile-packaging
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 (1)

All Lot Numbers With Expiration Date Prior To October 2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Atrium Medical Corporation 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 10 products in this recall →

Same manufacturer · Atrium Medical Corporation

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