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Medrad Inc recalls MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile
Recalled February 27, 2013 · FDA recall Z-0870-2013 · Medrad
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. · FDA Class II
Units
832,175
Sold at
Worldwide Distribution including USA nationwide.
Description
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.
Product
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.
Manufacturer(s)
Medrad Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →