FDA-Device2013-02-27Class II
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Medrad Inc
Hazard
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Sold states
Worldwide Distribution including USA nationwide.
Affected count
832,175
Manufactured in
100 Global View Dr, N/A, Warrendale, PA, United States
Products
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2013Don't want to check this manually?
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