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Medline Industries, Inc. DYNJ46042FRecalls & reported problems

Medline Industries, Inc. · SAHS CATH PACK · Class 2

Data updated Oct 18, 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 10193489908503), received between Dec 18, 2025 and Dec 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Connection Problem1
  • Incomplete or Inadequate Connection1

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.

  • MalfunctionDec 29, 2025Connection Problem; Connection Problem

    ACCORDING TO THE FACILITY ON 12/1/2025, THE SYRINGE IS BACKING OFF THE MANIFOLD. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS INTERRUPTED AND THE PRODUCT NEEDED TO BE REPLACED TO RESUME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23909109 ↗
  • MalfunctionDec 18, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

    IT WAS REPORTED THAT THE CONTROL SYRINGE "SPIRALED OFF" WHEN CONNECTED TO THE MANIFOLD AND ATTEMPTING TO PULL FLUID BACK ON (B)(6) 2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23838983 ↗

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Sources and updates

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