W L Gore recalls 20mm septal occluders with incorrect 3-year expiration date instead of 2 years. Affected units have serial numbers 22689696 to 23569078. Contact for replacement.
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 septal occluders that have an incorrect expiration date label (showing 3 years instead of 2). This could lead to improper use if the product expires earlier than intended.
The product is labeled with a 3-year expiration date instead of the correct 2-year expiration date. This could mean the device becomes ineffective or unsafe after the intended 2-year period if used without proper time management.
Medical professionals who use these devices for heart procedures are most at risk. Patients using the product under medical supervision are not directly affected by the expiration date error.
Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter' with serial numbers between 22689696 and 23569078. The product is sold only with a 3-year expiration date label.
Verify the expiration date label on the product matches the 2-year requirement for safe use.
The product is labeled with a 3-year expiration date instead of the correct 2-year expiration date.
The official recall notice does not specify a remedy or action steps for affected products.
The product may be safe if used within the intended 2-year period, but the incorrect label could lead to improper use.
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-0165-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0165-2022 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.
