GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code 511-00200-010; GEM2752; Lots SP19J09-1401617 and SP19J08-1401480
- 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:
- Baxter Healthcare Corporation
- Reason for Recall:
- The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Product Codes/Lot Numbers:
Product Code 511-00200-010; GEM2752; Lots SP19J09-1401617 and SP19J08-1401480
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1687-2020
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