Medline Industries, Inc. DYNJ82862ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327245030), received between Feb 17, 2023 and Mar 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2023Contamination; Tear, Rip or Hole in Device Packaging

  PRODUCT-MEDLINE CATH LAB PACK. THE STERILE BLUE WRAP HAD A TEAR/HOLE WHEN THE PLASTIC WRAP WAS REMOVED. PRODUCT NOT USED DUE TO COMPROMISED INTEGRITY. MANUFACTURER RESPONSE FOR CARDIAC CATHETERIZATION KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529156 ↗
• MalfunctionFeb 17, 2023Contamination /Decontamination Problem

  CATH LAB PACK OPENED FOR PREP OF PROCEDURE. WHEN THE PACK WAS OPENED, THERE WAS A BLACK HAIR. PACK NOT USED FOR PROCEDURE. MANUFACTURER RESPONSE FOR CARDIAC CATHETERIZATION KIT, (B)(4). (PER SITE REPORTER). SENDING REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16396256 ↗