Owen Mumford recalls 100-count packs of Unifine Pentips 5mm x 31G pen needles due to potential water exposure causing discoloration and sterility compromise. Affected units have specific UPC and batch numbers.
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Owen Mumford is recalling 100-count packs of Unifine Pentips 5mm x 31G pen needles because water in the packaging might compromise their sterility, which could lead to infections if used. This risk is specific to the packaging design and not the needles themselves.
Water exposure in the packaging can cause discoloring or yellowing of the protective seal, which might compromise the sterility of the needles. This could lead to infections if the needles are used after the seal is compromised.
People who use these pen needles for medical injections, especially those with specific UPC numbers and batch dates listed in the recall. The risk is low because the issue only affects packaging and not the needles.
Check for UPC #384703550018 with batch numbers AN 3550, Lot 1705722.S846 or AN 3550AC, Lot 1705122.S929. The product is a 100-count pack of sterile pen needles for medical injections.
Look for discoloration or yellowing on the protective seal of the packaging.
The recall does not specify if needles are safe if the seal appears normal. Check for discoloration or yellowing as a sign of potential compromise.
The recall does not provide a remedy, so contact Owen Mumford USA, Inc. for guidance on next steps.
Yes, check for UPC #384703550018 with batch numbers AN 3550, Lot 1705722.S846 or AN 3550AC, Lot 1705122.S929.
We’ve drafted a message you can send Owen Mumford to request your refund or repair — edit it as you like.
Subject: Recall Z-0381-2018 — Owen Mumford Owen Mumford Hello, I own a Owen Mumford that is covered by recall Z-0381-2018 from Owen Mumford. 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.
