Events

Recall of Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Mitek, Inc., a Johnson & Johnson Co..

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
    66145
  • Event Risk Class
    Class 2
  • Event Number
    Z-0192-2014
  • Event Initiated Date
    2013-08-29
  • Event Date Posted
    2013-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121553
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Pillow valve included in the fms duo outflow tubing set and the fms solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the one day set which may potentially lead to patient cross-contamination.
  • Action
    DePuy Mitek inititaed telephone notification on Ausgust 29, 2013 and sent an Urgent Voluntary Product Recall letter dated September 5, 2013 to US and OUS affected customers/affiliates. The customers were notified of the affected products, problem and actions to be taken. The customers were instructed to immediately check all inventories to locate and return affected product following the enclosed instructions. Stericycle is cooridianting the returns. If you have any questions or concerns in regards to this recall, please contact Stericycle directly at 1-866-737-1928.

Device

Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve
  • Model / Serial
    All lot codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
  • Product Description
    DePuy Mitek FMS Outflow Tubing with One-Way valve || Product Code:284649 || Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Manufacturer Address
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA