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FDASeptember 18, 2023device

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

What to do

FDA enforcement status: Ongoing

Brands named

atrium medicalatrium

UPCs

2065086211513420650862115141

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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