Events

Safety Alert for Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registration Number: 10330710065 Hazard Class: II Affected Model: 084120 and J-BICS-058020 Affected Lot / Serial Numbers: U2412468; U2412469; U2412470; U2413367; U2413911; U2429088; U2452670; 4,946,704; 4,965,697; 4,976,258; 4999997; 4,999,998; 5003247; 5007047; 4942636; 5,138,605; 5,141,718; 5,141,199; 5,145,105; 5,149,622; 5,149,623; 5,365,572; 5,365,642; 5,370,995; 5,388,926; 5509391; 5,518,548; 5,518,549; 5,593,065; 5,684,248; 5,718,485; 5,721,755; 5,737,801; 5,744,000; 5744001; 5,743,999; 5,766,046; 5,766,047; 5,789,746; 5794877; 5,798,213; 5,826,962; 5,973,018; 6008488; 5,978,226; 6008489; 6,056,601; 6073730; 6073731; 6127074; 6131751; 6131752; 6,142,020; 6,142,021; 6146513; 6146514; 6146518; 6228742; 6,242,198; 6371295; 6,375,171; 6,396,897; 6,396,898; 6214087; 6,247,244; 6255677; 6,262,720; 6,295,798; 6653171; 6719828; 6,519,829; 6,262,338; 6,360,647; 6,360,648; 6364334; 6371297; 6371298; 6,998,469; 7,012,893; 7,016,375; 7,016,376; 7,128,835; 7,134,480; 7162449; 7162450; 7162451; 7457006

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated.

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
    2245
  • Date
    2017-03-23
  • 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
    If direct skin or patient contact with overheated devices resulting in skin damage, including burns, it is recommended to seek medical attention.
  • Reason
    The cook medical group initiated voluntary recall of bush ureter illuminating catheters (references 084120 and j-bics-05802) due to the increased number of complaints that the black conductor in the proximal portion, which connects to the transparent component of the bush ureteral illumination catheter , it can overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes in contact with the patient's urethra, bladder, and ureter.
  • Action
    Field Action Code No.207 / RNC 031 - 032 / RA 018 triggered under the responsibility of Handle Comércio de Equipamentos Médicos Ltda. Company will collect.

Device

Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registrati...

Manufacturer

Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated
  • Source
    ANVSANVISA