Argyle 8888501023Recalls & reported problems
Cardinal Health, Inc. · Flexible Yankauer,Regular Capacity with Vent · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527019847), received between Oct 10, 2017 and Mar 27, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Decrease in Suction” (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
- Decrease in Suction1
- Defective Device1
- Device Slipped1
Patient problems
- No Known Impact Or Consequence To Patient1
- Respiratory Distress1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2018Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED THAT THE PRODUCT HAD VERY LITTLE CURVATURE AND THE SURGEON COULD NOT SUCK THE BLOOD PROPERLY IN THE THROAT OF A CHILD; CAUSING RESPIRATORY DISTRESS.
Patient problems: Respiratory Distress
MAUDE report 7373712 ↗MalfunctionOct 10, 2017Device Slipped; Defective Device
MANUFACTURING FOR THESE YANKAUERS ARE NOT CONSISTENT, CAUSING SOME TO SLIP OUT OF SUCTION TUBING WHEN CONNECTED. THEY COULD POTENTIALLY SLIP OUT OF SUCTION TUBING AND STAY IN PATIENTS (MOSTLY USED ON PEDIATRICS) THROAT WHEN SUCTIONING. HAVE 4 PACKAGES, SMALL ISSUE, SMALL LOT #.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6935762 ↗
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- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.