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Argyle 8888505164Recalls & reported problems

Cardinal Health 200, LLC · Yankauer Bulb Tip with On/Off Switch · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884527020003), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Suction Problem” (1 report).

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

  • Suction Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 7, 2017Suction Problem; Suction Problem

    THE CUSTOMER REPORTED PROCEDURE: AVR. PRODUCT WAS USED WITH PUMP OXYGENATORS. IT DID NOT ASPIRATED. THE CUSTOMER TESTED THE PRODUCT AFTER SURGERY, IT WAS CONFIRMED AIR LEAKED FROM CONNECTOR BETWEEN TUBING AND HANDLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6849079 ↗

Other CATHETER AND TIP, SUCTION devices

All CATHETER AND TIP, SUCTION devices →

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