Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Code: Model No: FEMII018A; UDI: 0069013031256; All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148
- 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:
- Edwards Lifesciences, LLC
- Reason for Recall:
- due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
Product Codes/Lot Numbers:
Lot Code: Model No: FEMII018A; UDI: 0069013031256; All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2084-2025
Related Recalls
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.