Recall Z-1397-2024 ยท HAW Neurological Stereotaxic Instrument
Elekta Instrument AB
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.
| Date | Apr 16, 2024 (initiated Mar 15, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Elekta issued an URGENT RECALL NOTIFICATION to its consignees on 03/05/2024 via email. The notice explained the problem, potential risk, and requested that the consignee advise appropriate personnel and destroy the affected product. |
| Quantity | 601 needles |
| Distribution | US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit Elekta Instrument AB, Mar 2, 2016 |