Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ProTimePROTIMEPST

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ProTimePROTIMEPST see related information
Date Initiated by Firm November 19, 2007
Date Posted January 25, 2008
Recall Status1 Terminated 3 on August 12, 2008
Recall Number Z-0547-2008
Recall Event ID 45809
510(K)Number K961835  
Product Classification Microcoagulation System - Product Code GJS
Product ProTime Microcoagulation System Instrument, Catalogue Number:
PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854
Code Information All instruments with Serial Number V56560 or lower. 
Recalling Firm/
Manufacturer		 International Technidyne Corporation
20 Corporate Pl S
Piscataway NJ 08854-6144
For Additional Information Contact
732-548-5700
Manufacturer Reason
for Recall		 An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.
FDA Determined
Cause 2		 Device Design
Action ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.
Quantity in Commerce 914
Distribution Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
-
-