Events

Recall of Intersurgical Breathing Circuit 22mm, nonconductive, single patient use

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intersurgical 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
    80250
  • Event Risk Class
    Class 2
  • Event Number
    Z-2302-2018
  • Event Initiated Date
    2018-04-25
  • 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=164961
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Reason
    When assembling an hme or filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. this could potentially pose a serious health risk to the patient.
  • Action
    On April 25, 2018, the firm issued an Urgent Medical Device Recall letter to its distributors. Customers were advised of the product issue and recall. Recall Instructions: 1. Immediately discontinue use and quarantine any stock with the product number B0062000 described above in this recall notification. 2. If you have distributed any of this product, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization Number (RGA). Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. 4. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: a. Return the completed form via email to Intersurgical Inc. at Support@intersurgicalinc.com. b. The subject line should contain your Company name and RGA number. i. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. 5. Intersurgical will credit your account when the product is received. If you have any other questions, feel free to contact Intersurgical Customer Support at 1-800-828-9633.

Device

Intersurgical Breathing Circuit 22mm, nonconductive, single patient use
  • Model / Serial
    0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributors in IL, NJ, NV, TX, UT.
  • Product Description
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Manufacturer Address
    Intersurgical Inc, 6757 Kinne St., E. Syracuse NY 13057
  • Manufacturer Parent Company (2017)
    Intersurgical Incorporated
  • Source
    USFDA