Events

Rappel de Device Recall Wound Closure Device

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 Zipline Medical.

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
    70466
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1235-2015
  • Date de mise en oeuvre de l'événement
    2015-02-05
  • Date de publication de l'événement
    2015-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133840
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Cause
    The manufacturers seal may not be present on the nylon pouch resulting in lack of assurance for sterility.
  • Action
    Zipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.

Device

Device Recall Wound Closure Device
  • Modèle / numéro de série
    Lot 1002750, Exp 2016-09
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
  • Description du dispositif
    Zip 8M Wound Closure Device; || for wounds up to 8 cm in length; || Product number PS9080; || Rx only, Sterile || Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
  • Manufacturer
    Zipline Medical

Manufacturer

Zipline Medical
  • Adresse du fabricant
    Zipline Medical, 747 Camden Ave Ste A, Campbell CA 95008-4147
  • Société-mère du fabricant (2017)
    Zipline Medical Inc.
  • Source
    USFDA