Home / Recalls / Blue Belt Technologies MN / Z-1995-2013

Z-1995-2013 Class II Terminated

Recalled by Blue Belt Technologies MN — Plymouth, MN

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