W L Gore recalls Cardioform Septal Occluder 30mm with incorrect 3-year expiration date instead of 2 years. Product sold in the US with specific serial numbers. No action needed for current users.
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 device because it has the wrong expiration date label. This could lead to potential issues with the device's safety and effectiveness if used after the correct expiration date.
The septal occluder has a label showing a 3-year expiration date instead of the required 2 years. This could mean the device might not be safe or effective after the correct expiration date.
Healthcare professionals who use this device for medical procedures may be affected. Patients using the device are not directly impacted by this recall.
Check for the product name 'GORE CARDIOFORM SEPT: 30 mm Diameter, Catheter Working Length 75 cm'. The device has a specific serial number range (22689696 to 23569078) and was sold outside the US.
Verify the expiration date on the device label; it should be 2 years instead of 3.
The product is safe to use if the expiration date is correct. This recall is due to an incorrect label, not a defect in the product itself.
No action is needed for current users as the product is safe if the expiration date is correct.
The serial numbers range from 22689696 to 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-0171-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0171-2022 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.
