Argon Medical recalls BioPince Ultra Full Core Biopsy Instruments with packaging holes that may cause infections. Affected models include 360-1080-01 to 370-1580-03 and specific lot numbers. Stop using if you have these items.
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
Argon Medical is recalling BioPince Ultra Full Core Biopsy Instruments because holes in the packaging trays can compromise the sterile barrier, potentially leading to infections. This affects specific model numbers and lot dates, and users should stop using these instruments to avoid introducing microorganisms into the body.
The packaging trays for these biopsy instruments have holes that can break the sterile barrier. This may allow microorganisms to enter the access site during procedures, potentially causing infections like bacteremia or sepsis.
Medical professionals who use the BioPince Ultra Full Core Biopsy Instruments for procedures. Patients undergoing biopsies with these instruments are at risk of infection if the packaging is compromised.
Check for model numbers starting with 360-1080-01 to 370-1580-03 or specific lot numbers listed in the recall notice. The instruments were sold with expiration dates ranging from March 2027 to May 2029.
If you have the recalled BioPince Ultra Full Core Biopsy Instruments, stop using them immediately to prevent potential infections.
The affected models include BioPince Ultra Full Core Biopsy Instruments with model numbers 360-1080-01 to 370-1580-03 and specific lot numbers listed in the recall notice.
Check the model number on your instrument and compare it to the list of affected models (360-1080-01 to 370-1580-03) and lot numbers provided in the recall notice.
Stop using the instrument immediately and contact Argon Medical for further instructions.
We’ve drafted a message you can send Argon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3192-2024 — Argon Medical Argon Medical Hello, I own a Argon Medical that is covered by recall Z-3192-2024 from Argon Medical. 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.
