NAMIC 80641482Recalls & reported problems
Medline Industries, Inc. · PML 48 ADULT FLL-MLL - OEM · Class 1
All models of NAMIC (667)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 40193489067485), received between Sep 25, 2026 and Sep 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925391 ↗MalfunctionSep 25, 2026Difficult or Delayed Separation
It was reported that Pressure monitoring tubing was stuck together. When customer pulled apart, the tubing split almost all the way through.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899004 ↗
Other MONITOR, LINE ISOLATION devices
- NAMIC 80641962Medline Industries, Inc. · MONITOR, LINE ISOLATION1 recall1 report
- NAMIC 80641722Medline Industries, Inc. · MONITOR, LINE ISOLATION1 recall0 reports
- NAMIC 90701122Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 90701362Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 90701482Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 80641242Navilyst Medical, Inc. · MONITOR, LINE ISOLATION1 report
- NAMIC 90701722Medline Industries, Inc. · MONITOR, LINE ISOLATION1 report
- NAMIC 90701482Navilyst Medical, Inc. · MONITOR, LINE ISOLATION1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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