Recall Z-1397-2024— Elekta Instrument AB

Name: FDA recall Z-1397-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-15

Class I · Ongoing

Class I FDA medical device recall by Elekta Instrument AB, initiated 2024-03-15. It names one FDA 510(k) clearance: K152558. Product: 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.. 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..

Recalling firm: Elekta Instrument AB
Classification: Class I
Status: Ongoing
Initiated: 2024-03-15
Firm location: Stockholm, Sweden

510(k) clearances named in this recall

1 on FDA's record

K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB·cleared 2016-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.