Events

Safety Alert for Restrictive moorings, body. Mooring, Restrictive mooring, arm. Restrictive mooring, wrist. Restrictive or supportive ties with safety buckles of Model 1070 manufactured between August 2000 and June 2001: (1) Cotton belts, with safety connectors and buckles, 18 to 72 inches, (2) Polypropylene belts with connectors (3) Connected TAT Ankle Cuff, (4) Connected TAT Wrist Cuff, (5) Locking TAT Ankle Cuff, (6) Locking TAT Ankle Cuff and Strap, (7) Locking TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, 2750, (3) 2795, (4) 2794, (5) 2793, (6) 2799, (7) 2801

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by J T Posey Co.

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
    328
  • Date
    2001-11-09
  • 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
    When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.
  • Action
    Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com.

Device

Restrictive moorings, body. Mooring, Restrictive mooring, arm. Restrictive mooring, wrist. Restri...

Manufacturer

J T Posey Co
  • Source
    ANVSANVISA