Angiotech recalls J Type Bone Marrow Needles with potential sterile seal defects that could compromise safety during medical procedures. Affected models include IMKBMN-13R-10 with lot numbers LF69, LFDA, LFL1.
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 J Type Bone Marrow Needles (13ga x 10 cm) due to a potential sterile seal defect in blister trays. This could lead to contamination risks during medical procedures if the seal fails.
The sterile seal on the blister trays may not form properly during manufacturing, potentially allowing contamination of the needles. This could compromise the safety of the medical procedure if the seal fails.
Medical professionals using these needles for bone marrow biopsies are most at risk. Patients receiving procedures with these needles may also be affected.
Check for model number IMKBMN-13R-10 and lot numbers LF69, LFDA, or LFL1 on the blister tray packaging. These needles are used for bone marrow biopsies and aspirations.
Verify the model number IMKBMN-13R-10 and lot numbers LF69, LFDA, or LFL1 on the blister tray packaging.
Argon Medical identified an internal manufacturing issue with the sterile seal formation on some blister trays for these needles.
The recall record does not specify a remedy, so no action is required beyond checking the product details.
The recall indicates a potential sterile seal defect that could compromise safety during medical procedures, but no specific injury risks are described.
We’ve drafted a message you can send Angiotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0815-2019 — Angiotech Angiotech Hello, I own a Angiotech that is covered by recall Z-0815-2019 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.
