Basic Series Hydrophobic Dressing Kit, Small 8463540 0583Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10851978007228), 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 16, 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 - LOUISIANA REPORTED QUALITY ISSUES WITH THE BASIC HYDROPHOBIC SMALL WOUND DRESSING KIT (P/N 0583, LOT 1596) AND BASIC HYDROPHOBIC MEDIUM KIT (P/N 0584, LOT 1614); TUBING WAS OBSERVED TO PULL APART OR BREAK AT THE STINGRAY CONNECTION. TWO ADDITIONAL UNITS OPENED BY THE CUSTOMER DID NOT EXHIBIT THE SAME FAILURE. 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 25566391 ↗