W L Gore & Associates, Inc. recalls GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could…
Read the official notice →- Date
- 2023-02-08
- Country
- United States
- Brand
- W L Gore & Associates
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Classification
- Class II
- Units
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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