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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm September 29, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on May 27, 2015
Recall Number Z-0491-2015
Recall Event ID 69541
510(K)Number K081459  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product Integra Selector Kit
Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval
Code Information Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. David E. Gronostajski, RAC
609-275-0500
Manufacturer Reason
for Recall		 Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
FDA Determined
Cause 2		 Device Design
Action Integra sent an 'Urgent- Medical Device Correction' letters/acknowledgement forms dated 9/29/2014 by traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product, complete the attached form. Complete the other information on the form and return the form by email or fax. Customers with questions should contact Customer Service at 1-855-532-1723.
Quantity in Commerce 6,358 tubing kits
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.
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 = LFL and Original Applicant = INTEGRA RADIONICS, INC.
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