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 22-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 sufficient documentation to prove they are sterile. This means they could be contaminated and cause infections during medical procedures.
Healthcare professionals and medical facilities using these needles for injections or fluid withdrawal. Patients receiving procedures with these needles are at risk of infection.
Look for needles labeled '22 G X 1.5 in REG BEVEL' in boxes of 100, with case numbers of 50 boxes per case. Known lot numbers include patterns like 12-6780-x through 15-9963-x.
Identify the lot numbers on the packaging, which follow patterns like 12-6780-x through 15-9963-x.
The recall is due to insufficient documentation supporting the product's sterility claims, which could lead to contaminated needles and infection risks.
Check for needles labeled '22 G X 1.5 in REG BEVEL' in boxes of 100, with case numbers including known lot patterns like 12-6780-x through 15-9963-x.
The recall does not specify a remedy, so contact the manufacturer for guidance on safe disposal or alternatives.
We’ve drafted a message you can send International Medsurg to request your refund or repair — edit it as you like.
Subject: Recall Z-2815-2017 — International Medsurg International Medsurg Hello, I own a International Medsurg that is covered by recall Z-2815-2017 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.
