Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6
Summary
The FDA issued a Class I for Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, by Elekta Instrument AB. Reason: Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the bi.
Details
Source
Device Recall
External ID
Z-1397-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot number 837838839 appears on the labels for REF 911933, REF 911761, and REF 912465. UDI numbers: REF 911933 - (01)0 7340048 30034 6, (17)250401 (10) 837838839 (240) 911933; REF 911761 - (01)0 7340048 30800 7, (17)250401 (10) 837838839 (240) 911761; REF 912465 - (01)0 7340048 30801 4, (17)250401 (10) 837838839 (240) 912465.
Quantity Affected: 601 needles
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.
Distribution
US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-15
Company
Stockholm
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 179 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Elekta Instrument AB has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta Instrument AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elekta Instrument AB have FDA actions?
Elekta Instrument AB has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1397-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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