Events

Safety Alert for Forceps for biopsy

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Alton (Shanghai) Medical Instruments Co., Ltd., China.

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
  • Event Number
    1
  • Date
    2017-03-07
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 recall data from the U.S. and Lithuania.
  • Extra notes in the data
  • Reason
    The label of the medical device does not contain information on the manufacturer's authorized representative in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); after checking the information in the european database of medical devices eudamed, the medical devices contained in this consignment were found not to be registered. eudamed has not found any chinese manufacturer alton (shanghai) medical instruments co., ltd., china, and its authorized representative in the european community (does not meet the requirements of paragraph 45 of the regulation); the label indicates that the medical device is non-sterile and reusable, but the method of sterilization is not specified (does not meet the requirements of annex 1, paragraph 14.3.13 of the regulation). the instructions for use are not included, no label or symbol on the label, instructions for use attached.
  • Action
    Not allowed to enter the Lithuanian market

Device

Forceps for biopsy

Manufacturer

Alton (Shanghai) Medical Instruments Co., Ltd., China
  • Manufacturers representative
    UAB Medex Baltic
  • Source
    MH