W L Gore recalls Cardioform Septal Occluder 30mm with 3-year expiration label instead of 2-year. Product sold outside US with specific serial numbers.
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
W L Gore is recalling a specific type of heart valve device due to an incorrect expiration date label. This could lead to product expiration issues if used after the intended timeframe.
The device has a 3-year expiration date label instead of the required 2-year expiration. This could mean the product expires earlier than intended, potentially affecting its safety and effectiveness.
Medical professionals who use the product for heart procedures may be affected. Patients receiving this device are at low risk since it's not for general consumer use.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter' with serial numbers between 22689696 and 23569078. The product is only sold outside the US.
Verify the expiration date on the product label; it should be 2 years instead of 3.
The product may be safe if used before the correct expiration date, but the label error could lead to premature expiration.
Medical professionals who use the product for heart procedures, as it's only sold outside the US.
Look for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter' with serial numbers between 22689696 and 23569078.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0172-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0172-2022 from W L Gore. 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.
