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U.S. Department of Health and Human Services

Class 2 Device Recall Percuvance Percutaneous Surgical System

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  Class 2 Device Recall Percuvance Percutaneous Surgical System see related information
Date Initiated by Firm September 09, 2016
Date Posted October 07, 2016
Recall Status1 Terminated 3 on August 25, 2017
Recall Number Z-0058-2017
Recall Event ID 75130
510(K)Number K143299  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709

The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
Code Information Lot Number 73M1500175
Recalling Firm/
Manufacturer
Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Melissa Lewis
610-378-0131
Manufacturer Reason
for Recall
The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
FDA Determined
Cause 2
Process control
Action The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" Letter dated 9/9/2016 to consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products listed; to return product- complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com even if you do not have the affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 160 ea. in total
Distribution US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
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 = GCJ and Original Applicant = Teleflex Medical, Inc.
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