Blue Belt Technologies MN: Medical Device Recall in 2013 - (Recall #: Z-1995-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 19, 2013

Date Posted: August 28, 2013

Recall Number: Z-1995-2013

Event ID: 65834

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

Status: Terminated

Product Quantity: 60 cartons (20 pieces/carton) 40 in EU, 20 in US.

Code Information:

Lot: D130432, expires February 2018

Distribution Pattern:

Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated