Events

Recall of Device Recall Percuvance 29cm Shaft

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77974
  • Event Risk Class
    Class 2
  • Event Number
    Z-3224-2017
  • Event Initiated Date
    2017-07-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158551
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. for certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated July 19 , 2017, to all affected consignees communicating the following on their recall of Percuvance Percutaneous Surgical System: Consignees were advised to take the following actions. 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. 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. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with any other questions, should contact their local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Percuvance 29cm Shaft
  • Model / Serial
    Lot #'s: 73B1600168, 73B1700525, 73C1600057, 73C1600152, 73C1600267, 73C1600327, 73D1600176, 73D1600481, 73E1600001, 73E1600662, 73F1600520, 73F1600594, 73F1600697, 73G1600015, 73G1600177, 73G1600178, 73G1600557, 73G1600730, 73H1600567,  73J1600182, 73M1600025, 73M1600026, 73M1600232, 73M1600233, and 73M1600328.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
  • Product Description
    Percuvance 29cm Shaft || The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville NC 27560-5437
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA