🔍 RecallPedia

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature

Class I - Dangerous
🏥 Medical Devices Recalled: November 9, 2015 C.R. Bard Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05
  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:
C.R. Bard, Inc.
Reason for Recall:
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature

Product Codes/Lot Numbers:

Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1617-2016

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