Events

Rappel de Intersurgical Breathing Circuit 22mm, nonconductive, single patient use

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Intersurgical Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80250
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2302-2018
  • Date de mise en oeuvre de l'événement
    2018-04-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164961
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Cause
    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
  • Modèle / numéro de série
    0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributors in IL, NJ, NV, TX, UT.
  • Description du dispositif
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Adresse du fabricant
    Intersurgical Inc, 6757 Kinne St., E. Syracuse NY 13057
  • Société-mère du fabricant (2017)
    Intersurgical Incorporated
  • Source
    USFDA