Angiotech recalls bone marrow needles with potential sterile seal defects that could compromise safety during medical procedures. Affected models include BMNJ-MEC-1110 with lot LHT1.
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 certain bone marrow needles due to a potential issue with the sterile seal on the blister trays. This could lead to contamination or infection during medical procedures if the seal fails.
The sterile seal on the blister trays may not form properly during manufacturing, potentially allowing contamination. This could lead to infection or other complications during bone marrow procedures if the seal fails.
Medical professionals using the recalled bone marrow needles for procedures are most at risk. Patients receiving these needles may also be affected if the seal fails.
Check for model number BMNJ-MEC-1110 and lot number LHT1 on the product packaging. The needles are 11ga x 10cm and 14MTWX x 12.5 cm in size.
Verify the model number BMNJ-MEC-1110 and lot number LHT1 on the packaging.
The recall is for a potential sterile seal defect that could lead to contamination during procedures, but the risk is low as the issue is identified in manufacturing.
Look for model number BMNJ-MEC-1110 and lot number LHT1 on the packaging. The needles are 11ga x 10cm and 14MTWX x 12.5 cm in size.
The recall does not specify a remedy, so contact Angiotech directly for guidance.
We’ve drafted a message you can send Angiotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0817-2019 — Angiotech Angiotech Hello, I own a Angiotech that is covered by recall Z-0817-2019 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.
