Z-1995-2013 Class II Terminated
FDA device recall Z-1995-2013 was initiated by Blue Belt Technologies MN on July 19, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated November 14, 2013). Affected quantity: 60 cartons (20 pieces/carton) 40 in EU, 20 in US..
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2013
- Initiation Date
- July 19, 2013
- Termination Date
- November 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Product Description
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.
Reason for Recall
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
Distribution Pattern
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Code Information
Lot: D130432, expires February 2018