FDA-Device2014-04-09Class II
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Teleflex Medical
Hazard
Complaints of leakage of insufflation gas through the device.
Sold states
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Affected count
55,521 total
Manufactured in
4024 Stirrup Creek Dr, N/A, Durham, NC, United States
Products
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2014Don't want to check this manually?
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