Events

Recall of Central Venous Tray, Triple Lumen Polyurethane

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
    57663
  • Event Risk Class
    Class 1
  • Event Number
    Z-1187-2011
  • Event Initiated Date
    2010-10-04
  • Event Date Posted
    2011-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97246
  • 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 LJS
  • 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.

Device

Central Venous Tray, Triple Lumen Polyurethane
  • Model / Serial
    Part number: C-UPICSY-4.0-CT-OTW   Global part number G49176;   Lot numbers: 2303832
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Product Description
    Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, , || 4.0 Fr/ 60 cm, UPICSY-4.0-CT-OTW, G49176, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Manufacturer
    Cook, Inc.

Manufacturer

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