W L Gore recalls Cardioform Septal Occluder 30mm with 3-year expiration label instead of 2-year. Product sold in US only 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 that has an incorrect expiration date label. This could lead to safety issues if used beyond the intended time frame.
The device has a label showing a 3-year expiration date instead of the required 2-year expiration date. Using it beyond the correct expiration date could lead to potential safety issues.
Medical professionals who use the device for heart procedures may be affected. Patients receiving the device are at risk if the expiration date is mislabeled.
Check for the product name 'GORE CARDIOFORM SEPTAL OC: 30 mm Diameter, Catheter Working Length 75 cm'. The serial numbers range from 22689696 to 23569078.
Verify the expiration date on the device label; it should be 2 years from the date of manufacture.
No, this product is not distributed within the US.
The correct expiration date is 2 years from the date of manufacture.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm' and 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-0169-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0169-2022 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.
