Alerta De Seguridad para First Aid Kits containing Lot # 0010004 Antiseptic Spray with Aloe Vera for Pain Relief Medi First Plus and / or Lot # 0003092 Antiseptic Medi First Plus Spray for Pain Relief. Products Nos: (1) 723REST, (2) 745LSC, (3) 756LSC, (4) P786GDX, (5) P956DX, (6) P964DX; Lot Nos .: (1) 5679, 5945; (2) 5681; (3) 5680; (4) 5802, 6587; (5) 4809, 5194, 6152, 6175, 6185; (6) 4301, 4425, 5125, 5700, 6614

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Textilease Medique Products [401916], 900 Lively Blvd, Wood Dale IL 60191 (distribuidor); York Pharmaceuticals Inc [401855], 1201 Douglas Ave, Kansas City KS 66103 (fabricante).

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    555
  • Fecha
    2002-03-08
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The first aid kits above, contain a spray to relieve burn and / or antiseptic spray that may be sub or super powerful. the distributor started a removal from its distributors by letter dated september 10, 2001. anvisa has provided the occurrence notification forms on the internet www.Anvisa.Gov.Br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. for further information, please contact anvisa's tecnovigilância unit, by e-mail tecnovigilancia@anvisa.Gov.Br or by telephone (61) 448-1485.
  • Acción
    Identify and isolate any affected product in your inventory. Return the affected product to your supplier, who in turn will return to Textilease Medique for reimbursement. For more information, contact your local Textilease Medique representative.