Cook Spectrum G23655Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter · Class 2
All models of Cook Spectrum (67)
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 00827002236554), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
Device problems
- Component Missing1
- Packaging Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2021Component Missing; Packaging Problem
COOK CATHETER CENTRAL VENOUS CATHETER TRAYS MANUFACTURED AFTER MARCH 1, 2021 DO NOT HAVE THE 22GA NEEDLE/25GA NEEDLE INSIDE THE KIT AS LISTED ON THE CONTENTS LIST. A LETTER WAS SENT TO MATERIAL WAREHOUSE WITH NOTIFICATION OF SUPPLY SHORTAGE ISSUE AS REASON KITS DO NOT HAVE NEEDLES PRESENT. THE INFORMATION WAS NOT DISTRIBUTED TO THE END USER LEVEL FROM MATERIALS MANAGEMENT. PROVIDERS ARE STERILE AND IN PROCESS OF INSERTING THE CENTRAL LINE AND PREPARING TO DRAW UP LIDOCAINE FOR LOCAL ANESTHESIA WHEN DISCOVER THE NEEDLES ARE NOT PRESENT. A DELAY IN INSERTION OCCURS WHILE ANOTHER STAFF MEMBER OBTAINS NEEDLES. A LABEL ON THE OUTSIDE OF THE PACKAGE WOULD NOTIFY THE END USER OF WHICH ITEMS CURRENTLY MISSING IN THE KIT AND ALLOW END USER TO OBTAIN NEEDED ITEMS PRIOR TO INSERTION AND PREVENTING DELAYS.
Patient problems: Insufficient Information
MAUDE report 11919392 ↗
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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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