Events

Recall of Solus Flexible wirereinforced laryngeal mask

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
    76945
  • Event Risk Class
    Class 2
  • Event Number
    Z-0208-2018
  • Event Initiated Date
    2017-04-03
  • 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=154650
  • 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
    Mask, oxygen - Product Code BYG
  • Reason
    A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
  • Action
    Intersurgical sent an Urgent Medical Device Recall Notice dated April 3rd, 2017, along with response forms to Customers. Customers were advised to immediately discontinue use and quarantine affected products. If affected products were further distributed, customers are advised to notify those individuals and advise them of the recall situation and have them return their outstanding stock to you. Customers with questions can call the IS Customer Service line at 800-828-9633 for a Return Authorization Number. Once customers receive the Return Authorization Number, please enter it in the space provided on the Recall Response Form. The completed Recall Response Form should be emailed to: Support@intersurgicalinc.com For further questions, please call (315) 451-2900)

Device

Solus Flexible wirereinforced laryngeal mask
  • Model / Serial
    Product Lots: 31402822 to 31610791
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
  • Product Description
    Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 || Patent airway management.
  • 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