Kroger AN 3590KRORecalls & reported problems
Kroger CO., The · Kroger Pentips, 6mm x 31G, 100 ct · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00041260007774), received between Mar 22, 2024 and Mar 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Separation Problem” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Separation Problem; Separation Problem
PATIENT WAS TAKING INSULIN LISPRO KWIKPEN INJECTION BEFORE MEAL AND THE INSULIN STOPPED AFTER ONLY 5 UNITS. WHEN SHE REMOVED THE PEN FROM HER STOMACH WHERE INJECTING SHE NOTICED THE NEEDLE WAS MISSING. HER SON TOOK A PAIR OF TWEEZERS AND REMOVED THE NEEDLE FROM HER SKIN. NO TREATMENT WAS NECESSARY.
Patient problems: Foreign Body In Patient
MAUDE report 18961608 ↗MalfunctionMar 22, 2024Separation Problem; Separation Problem
PATIENT WAS TAKING INSULIN LISPRO KWIKPEN INJECTION BEFORE MEAL AND THE INSULIN STOPPED AFTER ONLY 5 UNITS. WHEN SHE REMOVED THE PEN FROM HER STOMACH WHERE INJECTING SHE NOTICED THE NEEDLE WAS MISSING. HER SON TOOK A PAIR OF TWEEZERS AND REMOVED THE NEEDLE FROM HER SKIN. NO TREATMENT WAS NECESSARY.
Patient problems: Foreign Body In Patient
MAUDE report 18961606 ↗
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-0381-2018 · Nov 6, 2017 · TerminatedUnifine 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
- 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
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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