The Recall Desk
HighFDA (Devices)·Z-1938-2015·Announced 2015-07-08

Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring

Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.

What this means for you

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 structural defect (missing o-ring) that could compromise the device's function. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drain, Single Collection (P/N: 4000-100N) because the devices have a missing o-ring. The recall involves 390 cases of the product.

The affected devices were distributed nationwide in the United States, as well as in Canada and Germany. The specific lot number for the recalled product is 222516.

The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Affected units
390

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)

  • Lot Number: 222516

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →