Medrad Intego PET Infusion System, recall

January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Administration Sets used in nuclear imaging. The company said particulates can form inside the vials. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.

The company is recalling all product distributed between Oct. 9, 2008 to Oct. 11, 2016. This includes 86,172 products in the U.S. 

The Medrad Intego PET Infusion System controls and delivers medications from a chamber to a patient through a needle inserted into a vein during nuclear medicine procedures. Nuclear medicine procedures are used to diagnose and treat diseases such as cancer, thyroid disease, and heart disease.

Bayer has determined all Source Administration Sets used with the Medrad Intego PET Infusion System may produce a particulate matter in the medicine vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue and death.

On Nov. 7, 2016, Bayer sent an urgent medical device field safety corrective action notice to all affected customers. The notice asked customers to immediately discontinue the use and quarantine any unused affected product. It further instructed customers to retain the quarantined Source Administration Sets to be used when the new qualified in-line filter is received.Customers can also contact Bayer customer care at 800.633.7231, opt. 2, to receive a returned goods authorization number and return the product to Bayer.

To see a complete list of impacted batch numbers, go to www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm536548.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery


Related Content

News | Radiopharmaceuticals and Tracers

February 21, 2024 — Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next ...

Time February 21, 2024
arrow
News | Radiopharmaceuticals and Tracers

February 14, 2024 — PanTera, the Belgian joint venture created by IBA and SCK CEN to secure large-scale production of ...

Time February 14, 2024
arrow
News | Quality Assurance (QA)

February 12, 2024 — IBA, a world leader in particle accelerator technology and a world-leading provider of dosimetry and ...

Time February 12, 2024
arrow
News | PET Imaging

February 9, 2024 — A novel PET imaging technique can noninvasively detect active inflammation in the body before ...

Time February 09, 2024
arrow
News | Interventional Radiology

February 6, 2024 — RenovoRx, Inc., a clinical-stage biopharmaceutical company developing novel precision oncology ...

Time February 06, 2024
arrow
News | SNMMI

February 6, 2024 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) held its 2024 SNMMI Mid-Winter Meeting ...

Time February 06, 2024
arrow
News | FDA

January 23, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of syngo Virtual ...

Time January 23, 2024
arrow
News | Radiology Business

January 23, 2024 — Bayer announced Nelson Ambrogio as the new Head of the Radiology Business at its Pharmaceuticals ...

Time January 23, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

January 18, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling ...

Time January 18, 2024
arrow
Feature | PET-CT | By Melinda Taschetta-Millane

According to research conducted by Polaris Market Research, the global positron emission tomography (PET)/computed ...

Time January 17, 2024
arrow
Subscribe Now