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Argyle 8886864604Recalls & reported problems

Cardinal Health, Inc. · Luki Tube Specimen Collection Device · Class 2

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 30884527000108), received between Aug 20, 2019 and Aug 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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.

Most reported problems

Device problems

  • Crack2
  • Degraded2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2019Crack; Degraded; Crack; Degraded

    THE CUSTOMER REPORTED THAT THE DEVICE HAD EXTREMELY DRY TUBING THAT WAS CRACKING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8911097 ↗
  • MalfunctionAug 20, 2019Crack; Degraded; Crack; Degraded

    THE CUSTOMER REPORTED THAT THE DEVICE HAD A EXTREMELY DRY TUBING THAT WAS CRACKING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8910902 ↗

Other CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION devices

All CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.