SIGMA Spectrum Infusion Pump Recalled

November 23, 2010 – The U.S. Food and Drug Administration (FDA) has issued a class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. The recall has been issued because the pump has a tendency to fail suddenly without sounding an alarm.   The pump’s intended use was to deliver fluids through continuous and regulated injection to a patient in a hospital setting.

The pump is responsible for the regulated delivery of such medical essentials as:

  • solutions;
  • drugs;
  • agents;
  • nutritionals;
  • electrolytes;
  • blood; and
  • blood products.

When the pump fails suddenly, it causes the above listed fluids to be injected into the patient in inappropriate doses. These “inaccurate flow conditions” can result in a range of problems from back-flow to over-infusion, including the free-flow of medications into the body. Such a failure could lead to serious injury or even death. This recall by SIGMA affects machines with the serial numbers 706497 through 724065.  All healthcare facilities and practices have been required to make sure their Spectrum Infusion Pump does not fall within the given range of serial numbers. If the machine is among those listed, it must be returned to SIGMA. The pump is not to be used on any patient, including neonatal patients, for whom this sudden failure could cause especially adverse medical consequences, including death.  If you are concerned that your physician has been or will use one of the recalled pumps on yourself or a loved one, you are advised to contact your physician or the FDA. If you or a loved one has suffered serious injury because of the use of a defective medical device, it would be in your best interest to contact an experienced defective product lawyer.

Contacting a New York Defective Product Lawyer

When you have sustained a serious injury or lost a loved because of a defective product you are entitled to seek compensation for your damages and suffering. Consulting with a New York defective product lawyer can help you better understand your rights, determine liability for your injuries and decide if filing a defective product claim is right for you.  At Gacovino Lake & Associates we have formed a dedicated network of defective product lawyers that serve clients nationwide. Our New York office serves residents of the 5 boroughs with their auto accident, medical malpractice, defective drug, premises liability and Workers’ Compensation claims. For experienced help with your defective product claim, contact us today – 1-800-246-4878.

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