Medline Industries, Inc. PAIN1644Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489331141), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 16, 2024Class IIOpen, Classified

   The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

   Z-0512-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fitting Problem

  It was reported that "the thread does not fit through the connector for this lot number. The doctors have had to open multiple trays to get it to work."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895946 ↗