Events

Safety Alert for Central venous access kits MAC 2-Lumen with long obturators .. Catalog number: (1) AK-11142, (2) SI-11142; Lot. Numbers: (1) RF1020751, RF1031739, RF1031850, RF1033089, RF1043328, RF1044374; (2) RF0126277, RF1031741, RF1043329.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Arrow International Inc.

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 ID
    244
  • Date
    2001-09-28
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The above sets may leak fluid or air when the long obturator is inserted into the hemostasis valves. assemblies distributed after may 31, 2001 have a shorter shutter and are risk free. the manufacturer initiated the removal by means of a letter dated july 23, 2001.
  • Action
    Check receipt of the letter dated July 23, 2001 from the manufacturer Arrow International. Identify and isolate any affected product in inventory. Return any affected product to the above address to the care of Scott Carlisle, Quality Control Manager, Arrow International. The freight of the products will be free. The product exchange will be automatically posted at no cost upon presentation of return receipts. For further clarification or adjustments, please contact your local representative or telephone (610) 378-0131 (calls from outside the United States ).

Device

Central venous access kits MAC 2-Lumen with long obturators .. Catalog number: (1) AK-11142, (2) ...

Manufacturer

Arrow International Inc
  • Source
    ANVSANVISA