🔍 RecallPedia

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Class I - Dangerous
🏥 Medical Devices Recalled: April 15, 2021 Vygon U.S.A. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: 203373129 Exp. Date: June 30, 2022
  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:
Vygon U.S.A.
Reason for Recall:
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Product Codes/Lot Numbers:

Lot Number: 203373129 Exp. Date: June 30, 2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1689-2021

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