Medline Industries, Inc. DYNJ49366Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277847583), received between Feb 23, 2024 and Mar 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection 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. Nov 17, 2022Class IIOpen, Classified

   Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

   Z-1079-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT A "VESSEL CANNULA" WAS UNABLE TO CONNECT TO TWO (2) SYRINGE COMPONENTS FROM THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984462 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A HEPARIN NEEDLE DID NOT SECURE TO A SYRINGE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768801 ↗