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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

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.
Recall Number Z-1995-2013
Classification Class II
Code Info Lot: D130432, expires February 2018
Product Distributed Qty 60 cartons (20 pieces/carton) 40 in EU, 20 in US.
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 the bond joint.

Event Detail

Event Id 65834
Product Type Devices
Status Ongoing
Recalling Firm Blue Belt Technologies MN
City Plymouth
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.