Events

Recall of Device Recall Surgicutt Bleeding Time Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ITC-Nexus Dx.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66353
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-2014
  • Event Initiated Date
    2013-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122138
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, bleeding time - Product Code JCA
  • Reason
    Itc has determined that the blade in their surgicutt with blotting paper (product code: sub50i; lot: ak301m) devices may be loose.
  • 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.

Device

Device Recall Surgicutt Bleeding Time Device
  • Model / Serial
    Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Arizona andTexas. .
  • 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.
  • Manufacturer
    ITC-Nexus Dx

Manufacturer

ITC-Nexus Dx