Medline Industries, Inc. DYNJ80199ARecalls & reported problems
Medline Industries, Inc. · VEIN PACK · Class 2
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327040864), received between Sep 15, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 18, 2023Class IIOpen, Classified
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2165-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
- No Flow1
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 30, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950919 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported that "the tubing is very hard and stiff and it cracks/leaks under pressure while connected to the Klein pump that they are using during the vein ablation procedures."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773498 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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