Class I Recall Initiated for Bayer Medrad Intego Source Administration Sets

A Bayer Medrad Intego recall has been initiated for Medrad Intego PET Infusion System Source Administration Sets because the sets may produce particulate matter in the medicine vials. If particulate matter enters a patient, it could lead to serious adverse health consequences. Affected patients and their families may be eligible to seek compensation with the help of a defective medical device lawyer.

For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Bayer Medrad Intego recall lawyer who can assist you throughout the legal process.

Important: The time you have to pursue a claim is limited. Contact us for more information.

Airborne Particles Could Lead to Serious Adverse Health Consequences

Bayer is recalling Medrad Intego PET Infusion System Source Administration Sets because the sets may produce particulate matter (solid and liquid particles found in the air) in the medicine vials. The particulates are potentially created when the tip of the needle pushes through the rubber top of the vial. According to a safety alert issued by the U.S. Food and Drug Administration (FDA), “particulate matter could enter into the patient and cause serious adverse health consequences, including infection, damage of tissue and death.” Recalled Source Administration Sets were distributed between October 9, 2008, and October 11, 2016. Over 86,000 sets were recalled nationwide in the United States.

Those who may be affected include health care providers using the devices as well as all patient groups undergoing nuclear medicine diagnostic procedures involving Source Administration Sets with the Medrad Intego PET Infusion System.

The recall was originally initiated on November 7, 2016, when Bayer sent an urgent medical device field safety corrective action notice to all affected customers. The notice asked that customers immediately discontinue using the devices and to quarantine any unused affected product. Likewise, patients are encouraged to complete the response form indicating whether or not they have the affected product and if they will either retain the quarantined devices until they receive the inline filter or return the units to Bayer.

How a Bayer Medrad Intego Recall Lawyer Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by a defective infusion administration set may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group. You can fill out the form on this page or contact us by phone or email.

After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.