Owen Mumford recalls 30-count packs of Unifine Pentips 5mm x 31G pen needles due to potential water exposure causing discoloration and sterility compromise. Affected batches have UPC #384701150012 with specific 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 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 certain batches with known UPC and batch numbers.
Water exposure in the packaging can cause discoloring or yellowing of the protective seal, which may compromise the sterility of the needles. This could lead to infections if the needles are used after the seal is compromised.
People who own or use the Unifine Pentips 5mm x 31G pen needles for medical injections, particularly those with the specific batch numbers listed in the recall. Healthcare professionals and patients using these needles are most at risk.
Check for the UPC #384701150012 on the packaging. Affected batches include Batch No. AN 1150, Lot No. 1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; and Batch No. AN 1150HEB, Lot No. 1705722.T100.
Look for the UPC #384701150012 and specific batch numbers listed in the recall to confirm if your needles are affected.
The needles may be compromised by water exposure, which could lead to discoloration and sterility issues. Affected batches should not be used.
Check the packaging for the UPC #384701150012 and batch numbers. If affected, stop using them and contact Owen Mumford for further instructions.
Affected needles have specific batch numbers: Batch No. AN 1150, Lot No. 1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; and Batch No. AN 1150HEB, Lot No. 1705722.T100.
We’ve drafted a message you can send Owen Mumford to request your refund or repair — edit it as you like.
Subject: Recall Z-0382-2018 — Owen Mumford Owen Mumford Hello, I own a Owen Mumford that is covered by recall Z-0382-2018 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.
