Events

Recall of Device Recall PeelAway Introducer Set

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
    46151
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-2008
  • Event Initiated Date
    2007-12-07
  • Event Date Posted
    2008-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67056
  • 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 Introducer - Product Code DYB
  • Reason
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Action
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.

Device

Device Recall PeelAway Introducer Set
  • Model / Serial
    Lot Numbers: F2114474 and F2120414.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
  • Product Description
    Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
  • Manufacturer
    Cook, Inc.

Manufacturer

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