Events

Safety Alert for Hydrophilic cotton gauze

According to Digemid, this safety alert involved a device in Peru that was produced by L & M MERCANTIL S.R.L..

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
  • Date
    2015-03-06
  • Event Country
    Peru
  • Event Source
    Digemid
  • Event Source URL
    http://www.diresacusco.gob.pe/salud_individual/demid/alertas/alerdmid04-2015.pdf
  • Notes / Alerts
    Peruvian data is current through August 2018. All of the data comes from Digemid, 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 recall data from the U.S. and Peru.
  • Extra notes in the data
  • Reason
    The result for the average weight test does not meet the authorized technical specifications in its sanitary registry. the technical specifications for testing water-soluble substances differ from what is authorized for in the sanitary registry.

Device

Hydrophilic cotton gauze
  • Model / Serial
    Lot 106250 / Sanitary Registration # N-01127-IMM
  • Product Description
    Gauze
  • Manufacturer
    L & M MERCANTIL S.R.L.

Manufacturer

L & M MERCANTIL S.R.L.
  • Manufacturers representative
    L & M MERCANTIL S.R.L.
  • Source
    Digemid