Atrium Medical recalls a specific thoracic catheter model due to an inaccurate expiration date from sterilization issues. Affected units have a labeled expiry date of February 2023 but may expire earlier.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Atrium Medical is recalling a specific type of thoracic catheter because improper sterilization caused the expiration date to be labeled incorrectly. This means the catheter might be unsafe to use after the actual expiration date, potentially leading to complications.
The catheter was sterilized in a way that prematurely aged the product, causing the expiration date to be labeled incorrectly. This means the catheter could become unsafe to use before the actual expiration date, potentially leading to complications if used after the true expiration date.
Healthcare professionals using the Atrium Firm PVC Thoracic Catheter 36FR Straight with part number 15036 are most at risk. Patients receiving this catheter during treatment may also be affected.
Check for the part number 15036 on the catheter. The expiration date listed on the packaging is February 2023 (2023-02-24).
Verify the expiration date on the catheter packaging matches February 2023 (2023-02-24).
The catheter was sterilized in a way that prematurely aged the product, resulting in an inaccurate labeled expiration date.
Check the expiration date on the packaging. If it shows February 2023 (2023-02-24), it may be unsafe to use after the actual expiration date.
The official recall does not provide a fix or remedy for this issue.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0484-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0484-2024 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.
