Events

Recall of Device Recall Flexor CheckFlo Introducer

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
    73163
  • Event Risk Class
    Class 2
  • Event Number
    Z-0865-2016
  • Event Initiated Date
    2016-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143296
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Incorrect packaging. reports of packages labeled as 6.0fr actually containing 5.0fr devices.
  • Action
    On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. 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 Flexor CheckFlo Introducer
  • Model / Serial
    Catalog #:  KCFW-6.0-35-70-RB-HFANL0-HC  Lot: 6166304
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
  • Product Description
    Flexor Check-Flo Introducer, Catheter introducer, || Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC || Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
  • 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