FDAFDA · Alimentos y medicamentos·N.º oficial Z-1741-2017
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
Publicado el 12 de abril de 2017 · Inicio del retiro: 3 de marzo de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Product sterility is compromised due to breach of sterile barrier
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien LLC
- Distribuidor
- Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
- Lote
- Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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