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

ScImage and Invia Partnership Announced
News | Cardiac PACS| September 19, 2017
ScImage Inc. and Invia Imaging Solutions recently announced formation of a joint partnership at the American Society of...
CZT SPECT camera detectors offered by GE.

A display of CZT SPECT gamma camera detectors at RSNA 2016. These detectors are more sensitive than those used in older cameras, allowing for faster scans or lower radiation dose. 

Feature | Nuclear Imaging| September 19, 2017 | Dave Fornell
Cardiac nuclear myocardial perfusion imaging (MPI) has been a mature area of imaging for years, but has recently star
Philips Launches CardioMD IV Cardiac SPECT Solution at ASNC 2017
Technology | SPECT Imaging| September 15, 2017
September 15, 2017 — Philips highlighted its newest solution for...
ARTMS Products Inc. and GE Healthcare Team Up to Expand Cyclotron-Produced Radioisotopes
News | Radiopharmaceuticals and Tracers| August 30, 2017
ARTMS Products Inc. signed a strategic partnership with GE Healthcare around ARTMS’ proprietary QUANTM99 Irradiation...
Sponsored Content | Videos | Nuclear Imaging| August 24, 2017
Prem Soman, M.D., director of nuclear cardiology at the Heart and Vascular Institute, University of Pittsburgh, and p
Sponsored Content | Videos | Nuclear Imaging| August 24, 2017
Randy Thompson, M.D., attending cardiologist, St.
ASNC and SNMMI Release Joint Document on Diagnosis, Treatment of Cardiac Sarcoidosis
News | Cardiac Imaging| August 18, 2017
August 18, 2017 — The American Society of...
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
New PET-CT Scan Improves Detection in Rare Cardiac Condition
News | PET-CT| July 25, 2017
Using a new imaging technique that can diagnose cardiac sarcoidosis much more accurately than traditional tests,...
Overlay Init