Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6
FDA device recall Z-1397-2024 · posted 2024-04-16 · Open, Classified
Recall details
- Recalling firm
- Elekta Instrument AB
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HAW
- Quantity affected
- 601 needles
- Distribution
- US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
- Date initiated
- 2024-03-15
- Date posted
- 2024-04-16
- Location
- Stockholm, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit (K152558) | Elekta Instrument AB | 2016-03-02 |