Z-0137-2014Class II

Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison...

Name: Z-0137-2014 Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison...
Creator: ITC-Nexus Dx
Published: 2013-08-22
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2013-08-22 / Terminated / root cause: manufacturing process

FDA source

ITC-Nexus Dx began a recall of Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A... on 2013-08-22. FDA classified it as Class II and gives the reason as "ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0137-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Posted: 2015-06-26
Terminated: 2014-06-09
Recalling firm: Accriva Diagnostics, Inc.
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.
Product code: JCA Device, Bleeding Time
Reason for recall: ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ITC sent a Medical Device Recall letter dated September 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove/quarantine affected product in their inventory and to return the affected product to ITC. Customers with questions were instructed to call 1-800-631-5945. Questions regarding this recall call 732-548-7000, ext 4476.
Quantity in commerce: 6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
Distribution: Nationwide Distribution including Arizona andTexas. .
Product codes and lots: Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code JCA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)