Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Class I - DangerousWhat Should You Do?
- Check if you have this product: lot number 59860969.
- 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:
- The product failed to meet the internal established statistical test requirement for heparin activity.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Product Codes/Lot Numbers:
lot number 59860969.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1700-2015
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.