Recall of 5,000 hypodermic needles due to insufficient documentation supporting sterility claims. Affected products may pose infection risks if used improperly.
Insufficient documentation to support product sterility claims.
International Medsurg is recalling 5,000 boxes of 21-gauge hypodermic needles because the product lacks proper sterility documentation. Using these needles without verified sterility could lead to infections during medical procedures.
The needles were manufactured without adequate documentation proving they are sterile. This means they could be contaminated, potentially causing infections during medical procedures if used without proper sterility verification.
Healthcare professionals and medical facilities using these needles for injections or fluid withdrawal. Patients receiving procedures with these needles may face infection risks if sterility is not confirmed.
Check for the product name 'Hypodermic Needle, 21 G X 1.0 in REG BEVEL' with 100 per box, 50 boxes per case. Lot numbers starting with 12-6780-x through 15-9963-x are affected.
Verify if the product has documentation confirming sterility before use. If documentation is missing, do not use the needles.
The recall occurs because the needles lack sufficient documentation to support claims that they are sterile, which could lead to contamination and infection risks during medical procedures.
Look for the product name 'Hypodermic Needle, 21 G X 1.0 in REG BEVEL' with 100 per box and lot numbers starting with 12-6780-x through 15-9963-x.
The recall does not require returning the needles. However, users should verify sterility documentation before using them to avoid infection risks.
We’ve drafted a message you can send International Medsurg to request your refund or repair — edit it as you like.
Subject: Recall Z-2812-2017 — International Medsurg International Medsurg Hello, I own a International Medsurg that is covered by recall Z-2812-2017 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.
