Home / Recalls / ITC-Nexus Dx / Z-0137-2014

Z-0137-2014 Class II Terminated

Recalled by ITC-Nexus Dx — Edison, NJ

Recall Details

Product Type: Devices
Report Date: November 13, 2013
Initiation Date: August 22, 2013
Termination Date: June 9, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).

Product Description

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.

Reason for Recall

ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

Distribution Pattern

Nationwide Distribution including Arizona andTexas. .

Code Information

Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017