Atrium Medical recalls Oasis Dry Suction Water Seal Chest Drains with part number 3650-100 due to improper sterilization process by a third party. Affected units include specific lots; contact for remedy.
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Atrium Medical is recalling certain Oasis Dry Suction Water Seal Chest Drains because they were re-sterilized using an unapproved method. This could lead to infection or other complications if the device is used improperly.
The device was re-processed by a third party using sterilization methods not approved by the manufacturer. This could result in inadequate sterilization, potentially causing infections or other complications if the device is used.
Healthcare professionals and patients using the recalled chest drains. Those with the specific lot numbers listed are most at risk.
Check the product label for part number 3650-100. Look for lot numbers: 461817, 467572, 467849, 468617, 468855, 467191, 469401, 479253.
Look for part number 3650-100 and lot numbers listed in the recall notice.
The recall indicates the product was re-sterilized using an unapproved method, which could lead to infection risks. Do not use until the manufacturer confirms it's safe.
Check the product label for part number 3650-100 and lot numbers. If you have the affected lots, contact Atrium Medical for further instructions.
Look for part number 3650-100 and lot numbers: 461817, 467572, 467849, 468617, 468855, 467191, 469401, 479253.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0486-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0486-2024 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.
