ACS HGMA13ARecalls & reported problems
American Contract Systems, Inc. · MAJOR CATH LAB PACK · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072004932), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Contamination; Contamination
THE CUSTOMER ALLEGED THE STERILE LABELS ARE DISINTEGRATING. THIS INCIDENT OCCURRED WHILE TREATING A PATIENT. THE COLORING ON THE MEDICATION LABELS WAS RUBBING OFF. THE LABELS ARE INCLUDED IN CUSTOM PROCEDURE PACK AND UTILIZED TO LABEL SYRINGES AND MEDICATIONS. THE FLAKING OF THE LABEL WAS GETTING ALL OVER THE STERILE FIELD AND INSTRUMENTS AS WELL AS THE PHYSICIAN'S HANDS. ADDITIONAL INFORMATION WAS REQUESTED ON THREE SEPARATE OCCASIONS ON DECEMBER 18, 2024, DECEMBER 19, 2024, AND DECEMBER 30, 2024, WITH NO RESPONSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101005 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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