Elekta Instrument AB is recalling 601 Disposable Biopsy Needle Kits (Leksell Stereotactic System) because microscopic stainless steel debris was found inside the needles. While the debris is the same material as the needle and the needles remain sterile, this foreign material could be introduced into a patient during a biopsy procedure. This issue was identified at one clinical site and affects specific needles distributed in the U.S. and internationally. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this recall.
Microscopic stainless steel debris inside the biopsy needle may be accidentally injected or deposited into a patient's tissue during a procedure. This could potentially cause an adverse tissue reaction or other complications at the biopsy site.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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