Recall of 5,000 hypodermic needles due to insufficient documentation supporting sterility claims. Affected products include specific lot numbers and model types for medical use.
Insufficient documentation to support product sterility claims.
International Medsurg Connection is recalling 5,000 hypodermic needles because the product documentation does not adequately support claims that they are sterile. This could lead to infections if used improperly.
The needles were manufactured without sufficient documentation proving they meet sterility standards. This means there is a potential risk of contamination and infection if the needles are used in medical procedures without proper sterilization.
Healthcare professionals and medical facilities that use these needles for injections or fluid withdrawal. Patients using the needles for medical procedures are at risk of infection if the needles are not properly sterile.
Check for the product name 'Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case'. Look for lot numbers starting with 12-6780-x through 15-9963-x as listed in the recall.
Identify the product by checking the lot numbers listed in the recall notice (12-6780-x through 15-9963-x).
The recall is due to insufficient documentation supporting claims that the needles are sterile, which could lead to infection risks if used improperly.
The needles may not be sterile as claimed, so they should not be used without proper sterilization to avoid infection risks.
Check the lot numbers on the product packaging, which should match the list of numbers provided in the recall notice (12-6780-x through 15-9963-x).
We’ve drafted a message you can send International Medsurg Connection to request your refund or repair — edit it as you like.
Subject: Recall Z-2810-2017 — International Medsurg Connection International Medsurg Connection Hello, I own a International Medsurg Connection that is covered by recall Z-2810-2017 from International Medsurg Connection. 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.