Events

Recall of Device Recall Cook Spectrum

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
    Recall
  • Event ID
    75793
  • Event Risk Class
    Class 2
  • Event Number
    Z-0733-2017
  • Event Initiated Date
    2016-11-28
  • Event Date Posted
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151288
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Reason
    Cook medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. there have been no reports of illness or injury associated with this issue.
  • Action
    Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at fieldactionsna@cookmedical.com. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Device

Device Recall Cook Spectrum
  • Model / Serial
    catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835  Exp date 9/30/2018
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
  • Product Description
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray || Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA