Certified Mail-Return Receipt Requested
IMMEDIATE RESPONSE NEEDED
RE: HEALTH RISK FROM CONTAMINATED HEPARIN
Dear President or CEO:
The Food and Drug Administration (FDA) requests your immediate response as noted below.
On April 8, 2008, the FDA, Center for Devices and Radiological Health (CDRH) sent you a letter regarding your medical devices that may contain heparin or are heparin coated. In the letter, you were notified of serious adverse events potentially related to contaminated heparin. In addition, we asked that all device manufacturers and initial distributors of heparin containing or coated products assure that their products are contaminant-free. Specifically, we requested that all imported lots of heparin Active Pharmaceutical Ingredient (API) be tested by FDA recommended test methods: (http://www.fda.gov/cder/drug/infopage/heparin/default.htm - see “Screening Methods”). We also asked all manufacturers to submit to us within five (5) working days any adverse reactions related to the use of heparin containing or coated devices that may have caused or contributed to a death, serious injury, or reports of malfunctions in which the malfunction of the device was likely to cause or contribute to a death or serious injury if it were to occur.
FDA is requesting you provide the following information:
FAX this information to CDRH at 240- 276-0114 within the next 5 working days. If you have any questions, please call our heparin hot line at 1-866-751-5262. If you did not receive our April 8, 2008, letter, you may access a copy at http://www.fda.gov/cdrh/safety/heparin-notice.html.
Sincerely,
//S//
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
Updated May 9, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH