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U.S. Department of Health and Human Services

Class 2 Device Recall WECK Visistat 35R Disposable Skin Stapler

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  Class 2 Device Recall WECK Visistat 35R Disposable Skin Stapler see related information
Date Initiated by Firm March 24, 2017
Create Date May 17, 2017
Recall Status1 Completed
Recall Number Z-2108-2017
Recall Event ID 77102
Product Classification Staple, removable (skin) - Product Code GDT
Product WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO,
Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
Code Information 73H1600207
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Elizabeth Norwood
919-544-8000
Manufacturer Reason
for Recall		 Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
FDA Determined
Cause 2		 Error in labeling
Action Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees. The letter requested that they check inventory on hand and quarantine product for return. They letter also requested that distributors conduct a sub-recall. The letter included a reply form to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 3594 eaches
Distribution Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
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.
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