W L Gore recalls Cardioform Septal Occluder 25mm with incorrect 3-year expiration date instead of 2 years. 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 because it has the wrong expiration date label. This could lead to improper use if the device expires before intended.
The device is labeled with a 3-year expiration date instead of the required 2 years. If used after expiration, it may not function properly during medical procedures.
Medical professionals who use the device for heart procedures may be affected. Patients receiving the device are at low risk since it's not in regular use.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter' with serial numbers between 22689696 and 23569078. The product was not distributed within the US.
Verify the expiration date on the device label; it should be 2 years, not 3 years.
No, the product was not distributed within the US.
The correct expiration date is 2 years, but the device is labeled with a 3-year expiration date.
Look 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-0166-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0166-2022 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.
