CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Surgicutt fully automated incision making device recalled

Itc-Nexus Dx is recalling Surgicutt fully automated incision making device for bleeding time determination, distributed nationwide in the US. The recall was initiated on 22 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

Quantity recalled6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0137-2014
FDA event ID: 66353
Recalling firm: Itc-Nexus Dx, Edison, NJ
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2013
FDA classified: 4 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Aug 2013	Recall initiated by company
4 Nov 2013	Classified by FDA	+74 days
13 Nov 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including Arizona andTexas. .

Nationwide Arizona

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution including Arizona andTexas. .

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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30 Jul 2014Device	CLASS II	Hemochron Jr recalled by ITC-Nexus Dx	Itc-Nexus Dx	Other	GA, NY, VA
12 Feb 2014Device	CLASS II	Hemochron Jr recalled by ITC-Nexus Dx	Itc-Nexus Dx	Other	Nationwide

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