Elekta Disposable Biopsy Needles Recalled for Microscopic Internal Debris
Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Although no adverse events or injuries have been reported and the sterility of the needles remains unaffected, the FDA Class I classification requires a minimum severity score of 4 per the rubric.
Plain-English summary
Elekta Instrument AB is recalling Disposable Biopsy Needle Kits for the Leksell Stereotactic System (model REF 911933, 2.1mm diameter, 14 gauge). The recall involves 601 needles from batch lot number 837838839.
The needles have been found to contain microscopic debris on the inside. The debris is composed of stainless steel, the same material as the biopsy needle itself. The sterility of the biopsy needles has not been compromised, and no debris has been found on the outer surface of the needles. This issue has been identified at one site to date.
The affected needles have been distributed in the United States and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, and Switzerland.
Affected healthcare facilities and users should stop using the affected batch and contact Elekta Instrument AB for replacement or further instructions. No adverse events or injuries have been reported to date in connection with this issue.
The recalled product
- 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…
- Manufacturer
- Elekta Instrument AB
- Affected units
- 601
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distribution scope not specified by the agency.
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