Events

Recall of Stamey Needle

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
    77217
  • Event Risk Class
    Class 2
  • Event Number
    Z-2536-2017
  • Event Initiated Date
    2017-04-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155460
  • 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
    Carrier, ligature - Product Code GEJ
  • Reason
    Reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
  • Action
    On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. 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.

Device

Stamey Needle
  • Model / Serial
    All lots Catalog numbers: 095000; 095015; 095030; J-SYN-931600; J-SYN-931615; J-SYN-931630
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
  • Product Description
    Stamey Needle
  • 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