Cook Spectrum G48053Recalls & reported problems

Cook Incorporated · Spectrum, Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Double Lumen Polyurethane · Class 2

All models of Cook Spectrum (67)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002480537), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

Mar 6, 2020Terminated
The printed expiration dates are incorrect.
Z-1566-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Obstruction of Flow4

Patient problems

Insufficient Information3
Embolism/Embolus2
Thrombosis/Thrombus2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 27, 2023Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 17212892 ↗
MalfunctionJun 27, 2023Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 17212320 ↗
MalfunctionJun 27, 2023Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Embolism/Embolus; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 17212000 ↗
InjuryJun 27, 2023Obstruction of Flow; Obstruction of Flow
IN ADDITIONAL INFORMATION IT WAS REPORTED THAT THE CATHETER WAS PLACED ON (B)(6) 2023 IN THE RIGHT FEMORAL FOR ACCESS. THE PATIENT WAS SEDATED. UNUSED LUMENS WERE MAINTAINED VIA ORDERED HEPARIN-LOCK. DUE TO THE CLOTTING, TPA WAS ADMINISTERED ON (B)(6) 2023 AT 14:18HR, (B)(6) 2023 AT 03:53HR, (B)(6) 2023 AT 07:02HR, (B)(6) 2023 AT 11:55HR. ON (B)(6) 2023, A DEEP VEIN THROMBOSIS (DVT) WAS DIAGNOSED AND THE PATIENT RECEIVED ENOXAPARIN SODIUM ADMINISTRATION.
Patient problems: Embolism/Embolus; Thrombosis/Thrombus
MAUDE report 17211681 ↗

Device details

UDI-DI	`00827002480537`
Brand	Cook Spectrum
Model	G48053
Catalog no.	C-UDLMY-401J-ABRM-HC-IHI-FST
Company	Cook Incorporated
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 5, 2021

Device type (GMDN): Central venous catheterization kit, short-term

A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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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 · each recall links to the FDA recall notice
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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