NAMIC 64038301Recalls & reported problems
Medline Industries, Inc. · 3V STAR OFF MANIFOLD · 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 10193489059168), received between Sep 2, 2026 and Sep 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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
- Mar 24, 2026Open, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2139-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Disconnection1
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.
MalfunctionSep 2, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572198 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.