🔍 RecallPedia

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

Class I - Dangerous
🏥 Medical Devices Recalled: August 15, 2012 Sorin Group USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;
  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:
Sorin Group USA, Inc.
Reason for Recall:
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

Product Codes/Lot Numbers:

All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1186-2016

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