Reported Nov 13, 2024 · Ongoing
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6…
Elekta Instrument AB
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Instrument AB · Kungstensgatan 18 · Stockholm, N/A · N/A
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
911933 | Diameter / 14 Gauge, containing 6 inner boxes labeled |
911761 | Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of |
911761 | contains a Tyvek bag labeled |
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. |
- Lot codes and dates
- Batch Number 873874875R
- Package including 6 needlesUDI: (01)0 7340048 30034 6 (17) 260301 (10) 873874875R (240) 911933
- Package including 1 needleUDI: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761
- Inner sterile bag including 1 needleUDI: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
- Amount recalled
- 111 kits (666 needles)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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