🔍 RecallPedia

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2020 GA HEALTH COMPANY LIMITED Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267
  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:
GA HEALTH COMPANY LIMITED
Reason for Recall:
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

Product Codes/Lot Numbers:

Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0644-2021

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