ACS CDAV04DRecalls & reported problems
American Contract Systems, Inc. · CMC AV FISTULA · Class 2
Data updated Oct 13, 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 00191072029041), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2019Contamination /Decontamination Problem
STERILITY ASSURANCE ISSUE: FOUND A HAIR IN A STERILE PACK. NOTICED PRIOR TO PATIENT ENTERING ROOM. PACK AND ALL SUPPLIES REMOVED. NO DETRIMENT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8314518 ↗
Other General surgery tray devices
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- Medline Industries, Inc. DYNJ82007AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Halyard KRIV26-02_0003Avid Medical, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ63410Medline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ908124AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. CDS983467JMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 recalls0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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