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ITC-Nexus Dx recalls Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820
Recalled November 13, 2013 · FDA recall Z-0137-2014 · ITC-Nexus Dx
Hazard
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. · FDA Class II
Units
6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
Sold at
Nationwide Distribution including Arizona andTexas. .
Description
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Product
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.
Manufacturer(s)
ITC-Nexus Dx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →