Unifine Pentips Plus pen needles distributed with incorrect needle sizes
Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving incorrect needle sizes mixed into product packaging. No illnesses or injuries have been reported in the source. This is a risk-of-harm medical device mixup where patients could receive wrong-sized needles affecting proper insulin delivery.
Plain-English summary
Owen Mumford USA, Inc. is recalling Unifine Pentips Plus hypodermic pen needles due to a packaging error. Two cases of 4mm pen needles were inadvertently mixed into cartons labeled as 8mm pen needles.
Patients using the wrong needle size may experience improper medication delivery, difficulty with injection technique, or discomfort. The recalled product comprises 2,593 cartons of 100 needles per carton.
The recalled product was distributed nationwide to multiple U.S. states. Affected lot numbers are 20V4001.Z3999, 20V4001.Z4019, and 20V4001.Z411.
Patients and healthcare providers who have purchased affected cartons should stop using the product immediately and contact Owen Mumford USA with their lot numbers to request a replacement.
The recalled product
- Product
- Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Manufacturer
- Owen Mumford USA, Inc.
- Hazard
- mis-labeling
- wrong-needle-gauge
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers: 20V4001.Z3999
- Lot 20V4001.Z4019 and 20V4001.Z411
Distribution
Distributed nationwide across the United States.
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