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

NorthStar Medical Radioisotopes Completes Construction on Beloit, Wis. Molybdenum-99 Processing Facility
News | Radiopharmaceuticals and Tracers | July 16, 2019
NorthStar Medical Radioisotopes LLC  announced completion of construction on its 20,000-square-foot molybdenum-99 (Mo-...
Bracco Imaging Acquires Blue Earth Diagnostics
News | Radiopharmaceuticals and Tracers | July 01, 2019
Bracco Imaging S.p.A. has signed a definitive agreement to acquire Blue Earth Diagnostics, a molecular imaging company...
DOSIsoft Receives FDA 510(k) Clearance for Planet Onco Dose Software
Technology | Information Technology | June 20, 2019
DOSIsoft announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Planet...
United Imaging Announces First U.S. Clinical Install of uMI 550 Digital PET/CT System
News | PET-CT | June 19, 2019
United Imaging announced the first U.S. clinical installation of the uMI 550 Digital positron emission tomography/...
International Working Group Releases New Multiple Myeloma Imaging Guidelines

X-ray images such as the one on the left fail to indicate many cases of advanced bone destruction caused by multiple myeloma, says the author of new guidelines on imaging for patients with myeloma and related disorders. Image courtesy of Roswell Park Comprehensive Cancer Center.

News | Computed Tomography (CT) | June 17, 2019
An International Myeloma Working Group (IMWG) has developed the first set of new recommendations in 10 years for...
A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Magnetic Resonance Imaging (MRI) | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
BGN Technologies Introduces Novel Medical Imaging Radioisotope Production Method
News | Radiopharmaceuticals and Tracers | June 05, 2019
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for...
RefleXion Opens New Manufacturing Facility for Biology-guided Radiotherapy Platform
News | Radiation Therapy | May 31, 2019
RefleXion Medical recently announced the opening of its new manufacturing facility at its headquarters in Hayward,...
Study Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI

Image courtesy of MR Solutions.

News | PET-MRI | May 23, 2019
Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...