Kinray 1st Tier Unifine Pentips Plus AN 3840KIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00761059840190), received between Mar 4, 2019 and Mar 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2019Material Separation; Material Separation

  CUSTOMER STATED SHE HAS HAD MULTIPLE NEEDLES BREAK OFF IN HER SKIN DURING INJECTING INSULIN WITH LEVEMIR FLEXPEN, SPECIFICALLY TWO IN THE LAST WEEK. SHE DID NOT HAVE THE HUBS FOR THE NEEDLES THAT HAD BROKEN, SHE DOES HAVE SOME UNUSED PEN NEEDLES LEFT. SHE WAS INSTRUCTED TO MAKE AN APPOINTMENT WITH HER DOCTOR TO DISCUSS CHANGING NEEDLE LENGTHS, AS WELL AS TO EVALUATE THE NEEDLES THAT MAY BE IN HER SKIN. UPON RECEIPT OF THE MEDICAL QUESTIONNAIRE SHE INFORMED US SHE HAS DISCUSSED THE ISSUE WITH HER PRIMARY CARE PHYSICIAN ON (B)(6) 2018 AND THAT AS OF (B)(6) 2018, SHE OR HER PRIMARY CARE PHYSICIAN HAS NOT SEEN ANY VISIBLE SIGNS OF ANY PROBLEMS. NO FURTHER ACTION WAS TAKEN.

  Patient problems: Discomfort; Distress

  MAUDE report 8388167 ↗

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, Classified
  Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
• Z-0382-2018 · Nov 6, 2017 · Terminated
  Unifine 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
• Z-0381-2018 · Nov 6, 2017 · Terminated
  Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d