Atrium Medical recalls Ocean Water Seal Chest Drain devices due to unclear setup instructions that may delay treatment and cause patient harm. Affected units have specific lot codes.
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
Atrium Medical is recalling their Ocean Water Seal Chest Drain devices because the setup instructions are unclear, which could delay treatment and cause patient harm. This is a medical device used for chest drainage in hospitals and clinics.
The device has inadequate setup instructions that could lead to delays in treatment. This might cause harm to patients by not properly managing chest drainage or air buildup in the pleural space.
Healthcare professionals using the device in hospitals or clinics are most at risk. Patients receiving chest drainage treatment may be affected if the device is used incorrectly.
Check for lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651, 471703, 472562, 472785, 473725. The device is a plastic three-bottle vacuum collection system used for chest drainage.
Look for lot codes listed in the recall notice: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651, 471703, 472562, 472785, 473725.
It is a plastic, three-bottle vacuum collection device used for chest drainage in medical settings, consisting of a collection chamber, water seal chamber, and suction control chamber.
The recall is due to inadequate setup instructions that may delay treatment and cause patient harm.
Check the lot code on your device; affected units have specific lot codes listed in the recall notice.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0307-2022 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0307-2022 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
