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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot: D130432, expires February 2018 Class II 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. 60 cartons (20 pieces/carton) 40 in EU, 20 in US. Z-1995-2013