Atrium Medical recalls Express Mini 500 Dry Seal Chest Drains (Part 16400) due to insufficient safety instructions for home use, risking injury if misused 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 Express Mini 500 Dry Seal Chest Drains (Part Number 16400) because the safety instructions don't properly warn about using them outside medical settings or prevent improper drainage. This could lead to injury if someone tries to use the device incorrectly at home.
The device lacks clear instructions for safe use outside healthcare environments. Without proper warnings, users might drain the device incorrectly, potentially causing injury. The instructions also don't adequately prevent improper drainage during continued use.
People who own or use the Express Mini 500 Dry Seal Chest Drain (Part Number 16400) for home medical purposes are most at risk. Healthcare professionals using the device outside clinical settings may also be affected.
Check for the product name 'Express Mini 500 Dry Seal Chest Drain' with Part Number 16400. The device was manufactured 3 years before the recall started, and specific lot numbers are listed in the recall notice.
Review the Instructions for Use (IFU) to confirm if the device is safe for home use. If the IFU lacks warnings about home use, stop using it immediately.
Reach out to Atrium Medical Corporation for guidance on whether the device can be safely used at home or if it needs to be returned.
The recall states the Instructions for Use do not provide sufficient warnings for home use. Using it outside healthcare settings without proper instructions could be unsafe.
The recall lists specific lot numbers manufactured 3 years before the correction initiation. Check the product's lot number against the provided list.
The recall does not specify a return process. Contact Atrium Medical Corporation directly for instructions on what to do with the device.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1303-2023 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1303-2023 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.
