Events

Safety Alert for Disposable sterile needles for acupuncture 0.30X50 mm (25,000 pcs); 0.30X40 mm (30000 pcs); 0.35X75 mm (15000 pcs)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Beijing Zhongyan Taihe Medical Instrument 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
    2016-06-07
  • 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 individual packaging of medical devices does not indicate that the medical device is sterile (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.3); no individual batch / serial number on the individual packaging of medical devices (does not meet the requirements of mn 4: 2009 annex 1, clause 14.3.4); the individual packaging of medical devices does not indicate the date by which the medical devices can be used safely (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.5); there is no data available for an authorized representative in the european economic area (hereinafter referred to as "authorized representative in the eea") (does not meet the requirements of mn 4: 2009 annex 1 clause 14.3.1). please note that not all information on outer packagings and individual packs of medical devices is available in the european community language and therefore some information is not identifiable, the information in the leaflets accompanying the medical device is not in the european community language (does not comply with article 4 of council directive 93/42 / eec). (see point 4).
  • Action
    Disallowed to market

Device

Disposable sterile needles for acupuncture 0.30X50 mm (25,000 pcs); 0.30X40 mm (30000 pcs); 0.35X...

Manufacturer

Beijing Zhongyan Taihe Medical Instrument Co. Ltd., China
  • Manufacturers representative
    UAB Dainius Butvilas Clinic
  • Source
    MH