ITC-Nexus Dx: Medical Device Recall in 2013 - (Recall #: Z-0137-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 22, 2013

Date Posted: November 13, 2013

Recall Number: Z-0137-2014

Event ID: 66353

Reason for Recall:

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

Status: Terminated

Product Quantity: 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).

Code Information:

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

Distribution Pattern:

Nationwide Distribution including Arizona andTexas. .

Voluntary or Mandated:

Voluntary: Firm initiated