Events

Recall of Device Recall Codman 3000 Series Refill Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codman & Shurtleff, 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
    70659
  • Event Risk Class
    Class 2
  • Event Number
    Z-1684-2015
  • Event Initiated Date
    2015-03-05
  • Event Date Posted
    2015-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134356
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    Needle is leaking from hub/needle cannula connection.
  • Action
    Codman Neuro issued recall letter on 3/05/15 requested to immediately check all inventory to determine if you have affected product. Complete the Acknowledgement Form and follow the instructions to report your inventory status and return affected product for credit and replacement (if requested). General inquiries, customer service or field action logistics - please contact Codman Neuro Quality at: CodmanProductComplaints@DPYUS.JNJ.com or 866-491-0974.

Device

Device Recall Codman 3000 Series Refill Set
  • Model / Serial
    Lot numbers: 14B114CT, 14E011CT, and 14E366CT
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
  • Product Description
    CODMAN 3000 Series Refill Set- Huber needles. || Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump || CATALOG NO. : AP-07014 || Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. || .
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Manufacturer Address
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA