Basic Series Hydrophobic Dressing Kit, Small 8463540 0584Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10851978007235), received between Jun 19, 2026 and Jun 19, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

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.

• MalfunctionJun 19, 2026Material Separation; Gas/Air Leak

  CUSTOMER MEDCO - REPORTED QUALITY ISSUES WITH THE BASIC HYDROPHOBIC MEDIUM WOUND DRESSING KIT (P/N 0584, LOT 1616); TUBING WAS OBSERVED TO PULL APART OR BREAK AT THE STINGRAY CONNECTION. TWO UNITS OBSERVED WITH THE POTENTIAL DEFECT OF A CASE OF (b)(4) EACH DEVICES. DEVICES WERE NOT RETURNED. NO PATIENT WAS REPORTED TO HAVE BEEN INVOLVED. REPLACEMENT PRODUCT PROVIDED. CONSERVATIVE DETERMINATION: MDR REPORTABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566519 ↗