Angiotech recalls bone marrow biopsy needles due to potential sterile seal defects in blister trays. Affected models UCIN-16-5 with lot LK2L may risk contamination during use.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Angiotech is recalling bone marrow biopsy needles that may have defective sterile seals in their blister packaging. This could lead to contamination during surgical procedures if the needles are used without proper sterilization.
The sterile seal on the blister trays may not form correctly during manufacturing, potentially allowing contamination of the needles. This could lead to infections or other complications if the needles are used without proper sterilization.
Surgical teams and medical professionals using the recalled bone marrow biopsy needles for procedures. Patients undergoing bone marrow biopsies are at risk if the needles are used without proper sterilization.
Check for model number UCIN-16-5 and lot number LK2L on the blister tray packaging. The product is a bone marrow biopsy needle used for manual surgical procedures.
Verify the model number UCIN-16-5 and lot number LK2L on the blister tray packaging.
Argon Medical identified an internal manufacturing issue with the sterile seal formation on some blister trays for the Bone Marrow Biopsy Needle product line.
The recall record does not specify a remedy, so check the product details and contact the manufacturer if you have concerns.
The recall indicates a potential contamination risk if the needles are used without proper sterilization, but no specific injury mechanism is described.
We’ve drafted a message you can send Angiotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0818-2019 — Angiotech Angiotech Hello, I own a Angiotech that is covered by recall Z-0818-2019 from Angiotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
