W L Gore recalls Cardioform Septal Occluder 25mm 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 septal occluder that has an incorrect expiration date label (showing 3 years instead of 2). This could lead to potential issues with the product's safety and effectiveness.
The product is labeled with a 3-year expiration date instead of the required 2-year expiration date. This could potentially affect the product's safety and effectiveness over time, though the risk is low.
Medical professionals who use the product for cardiac procedures in the US. Patients receiving the product are not affected since it's not distributed within the US.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter' with serial numbers between 22689696 and 23569078. The product is not distributed within the US.
Verify the serial number is between 22689696 and 23569078 to confirm if it's affected.
No, the product is not distributed within the US.
The correct expiration date is 2 years, but the product is labeled with a 3-year expiration date.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 25 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-0170-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0170-2022 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.
