FDAFDA · Food and drugs·Recall number Z-0227-2025
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 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. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
Published November 13, 2024 · Recall initiated: September 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Elekta has become aware that Disposable Biopsy Needles 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Elekta Instrument AB
- Distributor
- US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
- Lot
- Batch Number 873874875R Package including 6 needles: UDI: (01)0 7340048 30034 6 (17) 260301 (10) 873874875R (240) 911933 Package including 1 needle: UDI: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761 Inner sterile bag including 1 needle: UDI: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- Sweden
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