Moderate FDA (Devices)·Z-0137-2014·Announced 2013-11-13

ITC Surgicutt Bleeding Time Device Recalled for Loose Blades

ITC-Nexus Dx is recalling Surgicutt bleeding time devices because the blades may be loose. The recall affects Lot AK301M distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loose blade which poses a risk of injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ITC-Nexus Dx is recalling the Surgicutt fully automated incision making device with Blotting Paper. The recall is due to a determination that the blade in the device may be loose. The affected product is identified by Product Code SUB50I and Lot Number AK301M, with an expiration date of August 31, 2017.

The recall covers 6 boxes, each containing 50 Surgicutt Devices and 55 sheets of Blotting Paper. The devices were distributed nationwide, including in Arizona and Texas. The Surgicutt device is a spring-loaded, cam-driven instrument used to provide standardized incisions of 5 mm length and 1 mm depth for bleeding time determinations.

Consumers and healthcare facilities should stop using the affected devices and contact ITC-Nexus Dx for further instructions. The company is located at 8 Olsen Avenue, Edison, NJ 08820, and can be reached at 732.548.5700.

The recalled product

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
Manufacturer: ITC-Nexus Dx
Category: Medical Device — Surgical Instruments
Hazard: loose-blade
cut-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · ITC-Nexus Dx

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