Reported Jan 24, 2018 · Terminated
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic,…
Owen Mumford USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Owen Mumford USA, Inc. · 1755 W Oak Commons Ct · Marietta, GA · 30062-2280
Is this the product you have?
Unifine Pentips 5mm x 31G pen needlespackaged in 100 ct pen needles
- Product UsageSterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors
- Lot codes and dates
UPC #384703550018: Batch No. AN 3550Lot No. 1705722.S846Batch No. AN 3550ACLot No. 1705122.S929
- Amount recalled
- 2,660 cartons (266,000 pen needles)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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