Recall of 5,000 hypodermic needles due to insufficient documentation supporting sterility claims. Affected products may not be sterile, risking infection during medical procedures.
Insufficient documentation to support product sterility claims.
International Medsurg is recalling 5,000 boxes of 25-gauge hypodermic needles because the product lacks proper sterility documentation. This could lead to infections if used for medical procedures.
The needles were manufactured without adequate documentation proving they are sterile. This means they might not be safe for medical use, potentially causing infections during procedures.
Healthcare professionals and medical facilities using these needles for injections or fluid withdrawal. Patients using the needles for medical procedures are at risk of infection if the needles are not sterile.
Look for needles labeled '25 G X 5/8 in REG BEVEL' with catalog number N3602558. The known lot numbers include patterns like 12-6780-x through 15-9963-x.
Verify the catalog number and lot numbers listed in the recall notice to confirm if your needles are affected.
The recall is due to insufficient documentation supporting the product's sterility claims, which could lead to infection risks during medical procedures.
No, the needles may not be sterile, so they could cause infections if used for medical procedures.
Check for the catalog number N3602558 and lot numbers starting with patterns like 12-6780-x through 15-9963-x.
We’ve drafted a message you can send International Medsurg to request your refund or repair — edit it as you like.
Subject: Recall Z-2819-2017 — International Medsurg International Medsurg Hello, I own a International Medsurg that is covered by recall Z-2819-2017 from International Medsurg. 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.
