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U.S. Department of Health and Human Services

Class 2 Device Recall Histolock Resection Device

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  Class 2 Device Recall Histolock Resection Device see related information
Date Initiated by Firm July 14, 2015
Date Posted October 01, 2015
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-0001-2016
Recall Event ID 71987
510(K)Number K140763  
Product Classification Snare, flexible - Product Code FDI
Product Histolock Resection Device, US Endoscopy.
An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Code Information M/N: 00711117; Lot #: 1505956
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Mrs. Kia (NMI) Pennington
800-769-8226
Manufacturer Reason
for Recall		 The company has determined the sterility cannot be assured for the affected lot.
FDA Determined
Cause 2		 Employee error
Action The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com.
Quantity in Commerce 41 units
Distribution US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
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 = FDI and Original Applicant = UNITED STATES ENDOSCOPY
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