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U.S. Department of Health and Human Services

Class 2 Device Recall Integra 3

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  Class 2 Device Recall Integra 3 see related information
Date Initiated by Firm March 11, 2016
Create Date April 28, 2016
Recall Status1 Terminated 3 on March 02, 2021
Recall Number Z-1584-2016
Recall Event ID 73581
510(K)Number K003142  
Product Classification Micromanipulators and microinjectors, assisted reproduction - Product Code MQJ
Product Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160

Product Usage:
The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
Code Information Serial numbers: 2-381
Recalling Firm/
Manufacturer		 RESEARCH INSTRUMENTS LTD - SITE B
Bickland Ind. Park
Falmouth United Kingdom
Manufacturer Reason
for Recall		 The units have been fitted with a potentially faulty power supply cable.
FDA Determined
Cause 2		 Device Design
Action Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions.
Quantity in Commerce 380 units
Distribution Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
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.
510(K) Database 510(K)s with Product Code = MQJ and Original Applicant = RESEARCH INSTRUMENTS LTD.
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