The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Class I - DangerousWhat Should You Do?
- Check if you have this product: To be reported.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vascutek, Ltd.
- Reason for Recall:
- The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Product Codes/Lot Numbers:
To be reported.
Distribution:
Distributed in: PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2543-2021
Related Recalls
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.