Angiotech recalls J-Type Bone Marrow Needles (11ga x 10 cm) due to potential sterile seal defects in blister trays. Affected models include IMKBMN-11R-10-X with lots LJUE, LEAC, LFKX and IMKBMN-11R-10 with lots LK0J, LEHU. No remedy specified in recall notice.
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 (11ga x 10 cm) because some blister trays may have defective sterile seals. This could lead to contamination during surgical procedures if the needle is used without proper sterility.
The sterile seal on the blister trays may not form correctly during manufacturing, potentially allowing contaminants to enter the needle packaging. This could lead to infection or contamination during surgical procedures if the needle is used without proper sterility.
Surgical professionals and medical facilities using the recalled needles for bone marrow biopsies are most at risk. Patients receiving procedures with these needles could face potential contamination.
Check for model numbers IMKBMN-11R-10-X (lots LJUE, LEAC, LFKX) or IMKBMN-11R-10 (lots LK0J, LEHU) on the needle packaging. The product is used for bone marrow biopsies and aspirations.
Verify the model number and lot numbers on the packaging to confirm if the needle is affected.
Argon Medical identified an internal manufacturing issue with the sterile seal on some blister trays for the Bone Marrow Biopsy Needle product line.
Model IMKBMN-11R-10-X with lots LJUE, LEAC, LFKX and Model IMKBMN-11R-10 with lots LK0J, LEHU.
The recall notice does not specify any remedy.
We’ve drafted a message you can send Angiotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0814-2019 — Angiotech Angiotech Hello, I own a Angiotech that is covered by recall Z-0814-2019 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.
