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U.S. Department of Health and Human Services

Class 2 Device Recall ProTimePROTIMEINT

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 Class 2 Device Recall ProTimePROTIMEINTsee related information
Date Initiated by FirmNovember 19, 2007
Date PostedJanuary 25, 2008
Recall Status1 Terminated 3 on August 12, 2008
Recall NumberZ-0548-2008
Recall Event ID 45809
510(K)NumberK951072 
Product Classification Microcoagulation System - Product Code GJS
ProductProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, 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
ActionITC 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 Commerce1,514 units
DistributionWorldwide-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 CycleTPLC 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) Database510(K)s with Product Code = GJS
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