enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number: 980202EU. All units distributed through March 7, 2019.
- 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:
- Vyaire Medical
- Reason for Recall:
- Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Product Codes/Lot Numbers:
Part Number: 980202EU. All units distributed through March 7, 2019.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1386-2019
Related Recalls
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Potential of the nozzle separating during patient use.