Atrium Medical recalls specific chest drain valves due to insufficient safety instructions for continued use and improper use outside healthcare settings.
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Atrium Medical is recalling certain chest drain valves because their safety instructions don't adequately warn about risks when used outside medical settings or for continued use. This could lead to unsafe conditions if the device is not properly managed.
The device's instructions don't provide enough warnings about using it outside healthcare settings or for continued use. This could lead to unsafe conditions if the device is not properly managed or if it's used without proper precautions.
Healthcare professionals and individuals who may have been using these chest drain valves outside of medical settings are affected. Those with improper use or lack of proper instructions are at higher risk.
Check for the part number 16100 on the valve. The affected lots were manufactured 3 years before the correction initiation date and include specific lot numbers listed in the recall notice.
Check if the device's instructions provide sufficient warnings about use outside healthcare settings and continued use.
Reach out to Atrium Medical for guidance on proper use or if the device needs to be replaced.
The instructions do not provide sufficient warnings about using the device outside healthcare settings or for continued use.
Affected lots include specific numbers listed in the recall notice, manufactured 3 years prior to correction initiation.
No, but you should review the instructions and contact Atrium Medical for proper guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1302-2023 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1302-2023 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.
