Angiotech recalls bone marrow biopsy needles with potential sterile seal defects. Affected models UCIN-15-5 (Lot LJ2T) may have compromised sterility 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. This could lead to infection risks during surgical procedures if the seal fails.
The sterile seal on some blister trays may not form properly during manufacturing. This could allow contamination of the needle during storage or use, increasing infection risk during procedures.
Surgical professionals using bone marrow biopsy needles with model UCIN-15-5 and lot number LJ2T are affected. Patients undergoing procedures with these needles face potential infection risks.
Check for model number UCIN-15-5 and lot number LJ2T on the blister tray. These needles are used for bone marrow biopsy and aspiration procedures.
Verify the model number UCIN-15-5 and lot number LJ2T on the blister tray.
The model number is UCIN-15-5.
Lot number LJ2T is affected.
Patients using these needles during procedures may face increased infection risk if the sterile seal fails.
We’ve drafted a message you can send Angiotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0820-2019 — Angiotech Angiotech Hello, I own a Angiotech that is covered by recall Z-0820-2019 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.
