Events

Recall of Reprocessed Electrophysiology Catheter Cables

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Sustainability Solutions.

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
    75941
  • Event Risk Class
    Class 2
  • Event Number
    Z-0964-2017
  • Event Initiated Date
    2016-12-06
  • Event Date Posted
    2017-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151793
  • 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, recording, electrode, reprocessed - Product Code NLH
  • Reason
    A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
  • Action
    Customer notification letters were sent 12/06/16. Customers were asked to use the criteria of Item Number and Expiration Date to determine if any affected product remains in inventory. Use of the products from the affected item number and expiration date should be discontinued. Customers are instructed to follow the web link below to complete the Recall Effectiveness Check Form and indicate if any devices with the affected item number and expiration date listed above remain in inventory. ONLINE form must be completed even if no affected product is found. Use Stryker Sustainability Solutions Ship To Account Number as complete the form. If do not know your Ship To Account Number, contact local sales representative or call Stryker Sustainability Solutions Customer Care at 1-888-763-8803 to obtain this number. If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to facility for all affected devices in scope of this recall that are returned. Address any questions regarding the recall to Novasyte by calling (760) 279-3126 or emailing sss151@novasyte.com. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1-888-763-8803 http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Reprocessed Electrophysiology Catheter Cables
  • Model / Serial
    All lots with the following Expiration Date Scope: Between 3/1/2018 and 10/31/2018 (Also displayed as Mar-2018 to Oct-2018)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA.
  • Product Description
    Reprocessed Electrophysiology Catheter Cables || Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT || Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA