Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100.
- 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:
- Intermittent communication due to inconsistent crimping of connectors onto cables.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Product Codes/Lot Numbers:
The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1928-2020
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due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.