News | Nuclear Imaging | January 12, 2017

Bayer Recalls All of its Medrad Intego PET Infusion System Source Administration Sets

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

Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
The Siemens Biograph Vision PET-CT system was released in mid-2018.

The Siemens Biograph Vision PET-CT system was released in mid-2018.

Feature | Nuclear Imaging | September 07, 2018 | By Dave Fornell
Nuclear imaging technology for both single photon emission computed tomography (SPECT) and positron emission tomography...
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Brain Study of 62,454 Scans Identifies Drives of Brain Aging
News | SPECT Imaging | August 27, 2018
In the largest known brain imaging study, scientists from five institutions evaluated 62,454 brain single photon...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer Patients
News | PET Imaging | August 09, 2018
In metastatic breast cancer, prognosis and treatment is largely influenced by estrogen receptor (ER) expression of the...
Novel PET Imaging Method Could Track and Guide Type 1 Diabetes Therapy
News | PET Imaging | August 03, 2018
Researchers have discovered a new nuclear medicine test that could improve care of patients with type 1 diabetes. The...
Researchers Trace Parkinson’s Damage in the Heart
News | PET Imaging | July 17, 2018
A new way to examine stress and inflammation in the heart will help Parkinson’s researchers test new therapies and...
Siemens Healthineers Announces FDA Clearance of syngo.via VB30 Molecular Imaging Software
Technology | Nuclear Imaging | July 16, 2018
At the 2018 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), June 23-26 in Philadelphia...