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U.S. Department of Health and Human Services

Class 2 Device Recall SureSight Obturator Introducer Localization Systems

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  Class 2 Device Recall SureSight Obturator Introducer Localization Systems see related information
Date Initiated by Firm August 02, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on March 30, 2017
Recall Number Z-2766-2016
Recall Event ID 74839
Product Classification Guide, needle, surgical - Product Code GDF
Product SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece

Product Usage:
The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
Code Information Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547. 
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information Contact SAME
508-263-8920
Manufacturer Reason
for Recall		 Tip Breakage at the glue joint between the obturator body and tip
FDA Determined
Cause 2		 Process control
Action Hologic sent an Important Product Recall letter to customers in the United States through Certified letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory and cease use of all affected recalled product. Customers were asked to complete the enclosed Recall Response Card indicating whether you have any of the recalled product on hand, as well as the quantity of product that you have in stock.
Quantity in Commerce 535 units
Distribution US Nationwide Distribution
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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