🔍 RecallPedia

S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

Class I - Dangerous
🏥 Medical Devices Recalled: September 19, 2012 Sorin Group USA Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913.
  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:
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

Product Codes/Lot Numbers:

Serial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0272-2013

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