FDAFDA · Alimentos y medicamentos·N.º oficial Z-1997-2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) 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 for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.
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: 20-11420, Lot Number: 023340, Expiration Date: 2/28/2017.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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