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Dear Colleagues,
The letter provided as a link to FDA's webpage has been sent to advise endoscope manufacturers to remove references to the SS1 from their product labeling and to assure that their labeling specifies only legally-marketed reprocessing devices. No action is required by healthcare facilities in response to the letter. Please disregard the previous posting and e-mail dissemination of this letter; it was premature.
The letter is available on FDA's website at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm201497.htm
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Regards,
Heidi C. Marchand, PharmD
Office of Special Health Issues
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(301) 827-4460