Events

Safety Alert for Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ’75, and Pereyra-Raz Ligature Carrier

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cook Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-04-25
  • Event Date Posted
    2017-04-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170425.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cook medical stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier. [catalogue identifiers: 1) j-syn-931630, j-syn-931615, j-syn-931600, 095030, 095015, 095000; 2) j-crkp-042900; 3) j-eie-051500; 4) j-plc-751810, 090100; 5) j-rsn-901600, 090002; lot numbers: all ]. the manufacturer has identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. their preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. there have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include localized surgical site infection to deeper organ space infection as well as chemical residual exposure. the manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. return or discard any affected products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 april 2017.

Device

Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Li...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ’75, and Pereyra-Raz Ligature Carrier
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical