Argyle 8888160556 (UDI 10192253040364)Recalls & reported problems
Cardinal Health 200, LLC · Argyle Polyurethane Umbilical Vessel Catheter Dual Lumen 5 Fr/Ch (1.7 mm) x 9-8/10"" (25 cm) 18/21 G (1.3/0.8 mm) 0.32 mL, 0.22 mL" · Class 2
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 10192253040364), received between Feb 10, 2026 and Feb 10, 2026 — 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-1874-2025 · Root cause: Package design/selection · FDA record ↗
Most reported problems
Device problems
- Connection Problem1
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.
MalfunctionFeb 10, 2026Connection Problem
THE CUSTOMER REPORTED THAT ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETERS ARE NOT STAYING CONNECTED TO THE STOPCOCKS. IT OCCURS WITH EVERY ONE OF THEM THAT THEY HAVE OPENED. THE CONNECTOR ENDS DO NOT LOCK, THE TABS SEEM TO BE SLIPPING IN THE LUERLOCK OF THE STOPCOCKS. THEY JUST KEEP SPINNING, AND IF THEY APPLY ANY PULLING PRESSURE, THEY CAN PULL THEM RIGHT OUT. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310720 ↗
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 8888160341Cardinal 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.