Unifine Pentips AN 3550Recalls & reported problems
Owen Mumford USA Incorporated · Unifine Pentips - 5mm x 31G · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384703550018), received between Aug 23, 2024 and Aug 23, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
1 FDA recall record name this device's identifier.
2 other recalls cover devices cleared under the same FDA submission (K152339); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 6, 2017Terminated
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.
Z-0381-2018 · Root cause: Environmental control · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Nonstandard Device1
- Use of Device Problem1
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2024Use of Device Problem; Use of Device Problem
WHEN A NEW NEEDLE IS OPENED, THE NEEDLE IS EXPOSED OUTSIDE OF THE NEEDLE CAP, AND PRICKED THE USER'S (NURSE) FINGER.
Patient problems: Needle Stick/Puncture
MAUDE report 20057908 ↗InjuryAug 23, 2024Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Manufacturing, Packaging or Shipping Problem
WHEN A NEW NEEDLE WAS OPENED, THE NEEDLE WAS EXPOSED OUTSIDEOF THE NEEDLE CAP AND IT PRICKED THE USER'S (NURSE) FINGER.
Patient problems: Needle Stick/Puncture
MAUDE report 20046785 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152339. One submission often covers many models, so check the product and lot details in each record.
- Z-2078-2021 · May 26, 2021 · Open, ClassifiedUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Z-0382-2018 · Nov 6, 2017 · TerminatedUnifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.