Device 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.
Z-1995-2013
Product summary
- Event
- Event 65834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 cartons (20 pieces/carton) 40 in EU, 20 in US.
- Official record key
device-enforcement:Z-1995-2013
Official wording
Reason: 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
Code information: Lot: D130432, expires February 2018
Distribution pattern: Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Derived failure modes
-
Unknown
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