Events

Recall of Device Recall SEDASYS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery 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
    71551
  • Event Risk Class
    Class 1
  • Event Number
    Z-2374-2015
  • Event Initiated Date
    2015-05-13
  • Event Date Posted
    2015-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138180
  • 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
    Computer-assisted personalized sedation system - Product Code PDR
  • Reason
    Ethicon has found that disinfecting methods not specified in the instructions for use (ifu) have led to the degradation of the plastic material of the sedasys system control unit.
  • Action
    Sedasys, a Division of Ethicon Endo-Surgery, Inc. sent an Urgent Customer Notification letter dated May 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Please distribute this information to all staff within your facility who use the SEDASYS System 2. Complete the Business Reply Form (BRF) (Attachment A) confirming receipt of this notice within three (3) business days. The BRF may be given to your sales or service representative or sent to Sedasys by email at SedasysTechSupport@its.jnj.com. 3. Keep this notice visibly posted in your facility for awareness. 4. If you have any questions or concerns regarding the condition of your SEDASYS System including the Control Units, please contact your Sales or Service Representative. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-800-SEDASYS (1-800-733-2797). If you need additional communications packages, contact 1-800-SEDASYS and reference Event 052715SED01. For questions regarding this recall call 513-337-7439.

Device

Device Recall SEDASYS
  • Model / Serial
    Model #SEDPRU01
  • Product Classification
    Anesthesiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including OH, RI, TX & WA.
  • Product Description
    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. || An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. || Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA