Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1088-2017·Announced 2017-02-01

Atrium Medical Express Mini 500 Dry Seal Drain Recall

Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.

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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Atrium Medical Corporation is recalling the Atrium Medical 16400 Express Mini 500 dry seal drain. The recall is due to a defect where the outer packaging is not sterile. This product is used 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 affects 964,463 cases in the United States and 521,975 cases outside the United States, for a total of 1,486,438 cases. The distribution is worldwide, including the US and numerous international locations such as Australia, Canada, China, France, Germany, and the United Kingdom. The specific units affected are those with all lot numbers and an expiration date prior to October 2019.

Healthcare providers and facilities should stop using the affected products and contact Atrium Medical Corporation for further instructions on returns or replacements. Patients who have already received the product should consult their healthcare provider if they have concerns regarding the sterility of the packaging.

The recalled product

Product: Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous…
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical Drains
Hazard: sterility
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 →

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