ZVU Functional GI Software, REF: ZVU-3

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
  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:
Diversatek Healthcare
Reason for Recall:
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ZVU Functional GI Software, REF: ZVU-3

Product Codes/Lot Numbers:

UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2521-2023

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