18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Publicado el 12 de diciembre de 2012 · Inicio del retiro: 21 de noviembre 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
The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Terumo Cardiovascular Systems Corporation
- Distribuidor
- Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.
- Lote
- catalog number: 7072 and lot number: 0602542, 0614871, and 0620810.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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