Argyle 8888160341 (UDI 10192253040319)Recalls & reported problems
Cardinal Health 200, LLC · Argyle Polyurethane Umbilical Vessel Catheter Single Lumen 5 Fr/Ch (1.7 mm) x 9-8/10" (25 cm) 0.41 mL Prime Volume" · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253040319), received between May 2, 2025 and May 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- May 2, 2025Open, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1873-2025 · Root cause: Package design/selection · FDA record ↗
Most reported problems
Device problems
- Connection Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
THE CUSTOMER REPORTED THAT IN THE PROCESS OF REMOVING AIR, SAMPLING PORTS " FLICKED" AND FLUID NOTICED TO COME OUT. THEY ATTEMPTED TO SECURE SAMPLING PORT, IT SPUN, NO SECURING SNUGLY/ BUT NOT COMING OFF. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT WHEN THE NURSE SAID THAT THE PRODUCT WAS ¿FLICKED¿, THEY'RE REFERRING TO HOW THEY "FLICK¿ THEIR LINES TO HELP MOVE AIR OUT OF THEM. SO THE NURSE SAW AIR IN THE LINE AND THEN FLICKED IT WITH THEIR FINGERS TO MOVE THE AIR UP TO A PORT SO IT CAN BE WITHDRAWN, BUT WHEN THEY DID THAT ACTION, FLUID CAME OUT/OFF OF THE LINE. THERE WAS NO CRACK OR BREAK IN THE SAMPLING PORT OR LINE. THE NURSES NOTED THE SAMPLING PORT WASN'T ON SECURELY AND WHEN THEY TRIED TO TIGHTEN IT, IT JUST SPUN ON THE THREADS AND WOULDN'T LOCK. WHEN THEY TRIED TO ATTACH ANOTHER SAMPLING PORT THE SAME THING HAPPENED. NOTHING WOULD SECURE TO THE UMBILICAL LINE, SO THEY HAD TO REMOVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950612 ↗
Other CATHETER, UMBILICAL ARTERY devices
- Argyle 8888160333Cardinal Health, Inc. · CATHETER, UMBILICAL ARTERY2 deaths66 reports
- Argyle 8888160333Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall7 reports
- Argyle 8888160556Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall1 report
- Argyle 8888160119Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160648Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160325Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160341Cardinal Health, Inc. · CATHETER, UMBILICAL ARTERY36 reports
- Argyle 8888160531Cardinal Health, Inc. · CATHETER, UMBILICAL ARTERY23 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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