FDA-Device2013-08-28Class II
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.
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
Sold states
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Affected count
60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Manufactured in
2905 Northwest Blvd Ste 40, N/A, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2013Don't want to check this manually?
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