FDAFDA · Alimentos y medicamentos·N.º oficial Z-1996-2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
Publicado el 18 de julio de 2012 · Inicio del retiro: 1 de junio de 2012
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
Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PSC Industries Inc
- Distribuidor
- Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
- Lote
- Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States