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U.S. Department of Health and Human Services

Class 2 Device Recall Surgicutt Bleeding Time Device

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  Class 2 Device Recall Surgicutt Bleeding Time Device see related information
Date Initiated by Firm August 22, 2013
Create Date June 26, 2015
Recall Status1 Terminated 3 on June 09, 2014
Recall Number Z-0137-2014
Recall Event ID 66353
Product Classification Device, bleeding time - Product Code JCA
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.
Code Information Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
Recalling Firm/
Manufacturer		 ITC-Nexus Dx
23 Nevsky St
Edison NJ 08820-2425
For Additional Information Contact Ms. Ellie Fox
732-548-7000 Ext. 4476
Manufacturer Reason
for Recall		 ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
FDA Determined
Cause 2		 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. .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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