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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66353
Product Type Devices
Status Ongoing
Recalling Firm ITC-Nexus Dx
City Edison
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including Arizona andTexas. .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017 Class II ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper). Z-0137-2014