🔍 RecallPedia

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

Class I - Dangerous
🏥 Medical Devices Recalled: March 27, 2020 Edwards Lifesciences Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Sterile catheter kit packaging compromised.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

Product Codes/Lot Numbers:

Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932

Distribution:

Distributed in: US, AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2007-2020

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