Reported Apr 24, 2024 · Ongoing
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing…
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
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
911933 | 2.1mm 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. |
- Amount recalled
- 601 needles
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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