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Blue Belt Technologies MN recalls Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended us
Recalled August 28, 2013 · FDA recall Z-1995-2013 · Blue Belt Technologies MN
Hazard
Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at · FDA Class II
Units
60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Sold at
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Description
Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
Product
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Manufacturer(s)
Blue Belt Technologies MN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →