Recall of Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 1
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Reason
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Action
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.


  • Model / Serial
    Part number: C-UDLMY-801J--RSC-MNP-ABRM-HC-FST-A, Global part number G44070 Lot number: 2238963, 2238964, 2238967, 2238970, 2240532, 2248247, 2291832 and 2296248.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Product Description
    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 20cm, C-UDLMY-801J-RSC-MNP-ABRM-HC-FST-A, G44070, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Manufacturer


  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source