W L Gore recalls Cardioform Septal Occluder 20mm 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 septal occluder that has an incorrect expiration date label (showing 3 years instead of 2 years). This could lead to potential issues with the product's safety and effectiveness if used beyond its intended shelf life.
The septal occluder has a label showing a 3-year expiration date instead of the correct : 2 years. This could mean the product might not be safe or effective after the intended shelf life, though the risk is low due to medical use protocols.
Healthcare professionals who use this specific septal occluder for medical procedures may be affected. Patients receiving this device are at low risk since it's a medical product with strict usage protocols.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter' with serial numbers between 22689696 and 23569078. The product is not distributed within the US, so it's only relevant for medical use outside the US.
Look for the expiration date label on the product; it should read '2 years' instead of '3 years'.
The product may be safe for medical use, but the incorrect expiration date could affect its effectiveness after the intended shelf life. Always follow medical guidelines.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter' with serial numbers between 22689696 and 23569078.
The recall record does not specify a remedy.
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-0167-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0167-2022 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.
