Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
Publicado el 24 de abril de 2024 · Inicio del retiro: 15 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Elekta Instrument AB
- Distribuidor
- US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
- Lote
- Lot number 837838839 appears on the labels for REF 911933, REF 911761, and REF 912465. UDI numbers: REF 911933 - (01)0 7340048 30034 6, (17)250401 (10) 837838839 (240) 911933; REF 911761 - (01)0 7340048 30800 7, (17)250401 (10) 837838839 (240) 911761; REF 912465 - (01)0 7340048 30801 4, (17)250401 (10) 837838839 (240) 912465.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- Sweden
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