inforMED
MalfunctionFMK

CARDINAL HEALTH UNISTIK 3 NORMAL

Received Jun 26, 2026

Report 1058602-2026-00009 · MDR key 25641990

Device

Generic name

Lancet

Model number

AT 6201

Lot number

12648

Product problems

  • Retraction Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE GRAY TWIST TOP THAT YOU HAVE TO PULL OFF ISN'T COMING OFF EASILY AS IT SHOULD, AND THE NEEDLE DOESN'T RETRACT AT ALL AFTER USE- IT IS STICKING OUT ABOUT 8TH OF AN INCH.