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:
- Has your company, including any subsidiaries or contractors, manufactured any medical devices that contain heparin which may still be available for clinical use, i.e., on the shelf or otherwise in distribution, or that have been implanted over the past two years? If not, then please inform us and no further information is necessary at this time.
- If so, identify the source of the heparin API or raw heparin used in the production of your heparin-containing devices, e.g., manufacturer/distributor name and address, lot number(s), date received, and type of heparin.
- Provide a list of your devices containing heparin (Product and Trade Name).
- For all the heparin-containing devices listed, describe specifically for each device how you have verified that all lots of heparin used in the manufacture of each type of device have been tested for contaminant by the methods noted above. For example, for each device, report all lots tested and passed, report partial results, report the expected test completion date, or report product not tested and explain why.
- If any contaminated heparin was used in any production as determined by a test result or if you have not initiated or completed tests, describe the actions you are taking to ensure the minimization of risk to the public.
- Describe how you intend to ensure that lots of heparin received in the future will be contaminant free.
- Report any information that will be helpful to identify additional contaminated heparin sources.
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 April 8, 2008 NOTICE .
Timothy A. Ulatowski
Office of Compliance
Center for Devices and