Z-0227-2025 Class I Ongoing
FDA device recall Z-0227-2025 was initiated by Elekta Instrument AB on September 25, 2024 and is designated Class I. Reason for recall: 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 biops… The recall status is ongoing. Affected quantity: 111 kits (666 needles).
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- September 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 kits (666 needles)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
Code Information
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