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Cardiogen

Rubidium Rb 82 Generator

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed touse CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82.

Rubidium Rb 82 Generator

DESCRIPTION Cardiogen-82 ® (Rubidium Rb 82 Generator) contains accelerator produced strontium Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means for obtaining sterile nonpyrogenic solutions of rubidium chloride Rb 82 injection.

Dear Valued Customer,

As mentioned in previous communications, we implemented several additional initiatives to facilitate our review and outcome efforts. o CardioGen-82 Generator Voluntary Recall Process: We appreciate your cooperation in expeditiously shipping the recalled generators back to LANL and submitting the ...

Frequently Asked Questions

Bracco CardioGen-82 Recall Frequently Asked Questions Q1. Why did the CardioGen-82 recall occur? A1. It has been reported that strontium breakthrough from generators used to administer Rubidium (Rb-82) occurred at two separate sites.

IMPORTANT SAFETY INFORMATION: Disseminate to all health care ...

July 13, 2011 RE : Reports of unexpected radiation exposure to patients: Reminder for mandatory daily procedure to check for strontium-82 or strontium-85 (Sr-82, Sr-85) breakthrough when using CardioGen-82 ® (Rubidium Rb 82 Generator) Dear CardioGen User: Gamma ray emissions from strontium ...

RE: CardioGen-82 (Rubidium Rb82 Generators)

1850 Samuel Morse Drive, Reston, VA 20190-5316 P: 703.708.9000 F: 703.708.9015 www.snm.org August 3, 2011 Margaret Hamburg, MD Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue White Oak Campus, Silver Spring, MD 20993 RE: CardioGen-82 (Rubidium Rb82 ...

FSME-11-076, July, Other, Cardiogen-82 Rubidium-82 Generator

Purpose: To provide the Agreement States with a copy of the U.S. Food and Drug FSME-11-076, July, Other, Cardiogen-82 Rubidium-82 Generator

Nevada State Health Division

Page 1 of 1 Nevada State Health Division Technical Bulletin Topic: Immediate Cessation of the Use of CardioGen-82 PET Scan Section/Program/Contact: Ihsan Azzam, M. D., MPH - Nevada State Epidemiologist Date: July 2011 TO: Health Care Providers and Public/Medical Imaging Providers ...

RE: NDA #18-735, 20-327

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Melanie Benson Director, US Regulatory Affairs Bracco Diagnostics Inc. 107 College Road East Princeton, NJ 08540 RE: NDA #18-735, 20-327 Isovue ® (iopamidol ...

PRICES EFFECTIVE: August 1, 2009 BRACCO DIAGNOSTICS INC.

Sets may not be returned for credit CARDIOGEN-82® ELUTION VIAL SHIELD 001550 $35.54 Cardiogen-82 Elution Vial Shield may not be returned for credit CARDIOGEN-82® ASSEMBLY EXTENSION TUBING 001562 $56.30 Cardiogen-82 Assembly Ext. Tubing may not be returned for credit CARDIOGEN-82® INFUSION SYSTEM THERMO ...