Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Textilease Medique Products [401916], 900 Lively Blvd, Wood Dale IL 60191 (distribuidor); York Pharmaceuticals Inc [401855], 1201 Douglas Ave, Kansas City KS 66103 (fabricante).

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
    555
  • Date
    2002-03-08
  • 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 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.
  • Action
    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.

Device

First Aid Kits containing Lot # 0010004 Antiseptic Spray with Aloe Vera for Pain Relief Medi Firs...

Manufacturer

Textilease Medique Products [401916], 900 Lively Blvd, Wood Dale IL 60191 (distribuidor); York Ph...
  • Source
    ANVSANVISA