🔍 RecallPedia

Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Class I - Dangerous
🏥 Medical Devices Recalled: June 15, 2015 Sorin Group USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product code 16-02-83 Serial number 16S11455-16S15190
  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:
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product Codes/Lot Numbers:

Product code 16-02-83 Serial number 16S11455-16S15190

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2079-2015

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