Events

Rappel de Device Recall Insulet OmniPod

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 Insulet Corporation.

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
    71651
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2484-2015
  • Date de mise en oeuvre de l'événement
    2015-07-13
  • Date de publication de l'événement
    2015-09-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138558
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Cause
    Omnipods¿ (pods) have a higher rate of failure causing: cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the pdm and pod will not deliver insulin.
  • Action
    The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods: 1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method). 2. Return the enclosed reply card by mail or fax to 1-855-407-3729. 3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night). If you do not have any unused Pods form these lots, reply using one of the methods above. If you have any question, contact Acting VP RA/QA at 978-600-7000. EXPANDED RECALL: Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification

Device

Device Recall Insulet OmniPod
  • Modèle / numéro de série
    Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250  Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and country of: Switzerland.
  • Description du dispositif
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
  • Manufacturer
    Insulet Corporation

Manufacturer

Insulet Corporation
  • Adresse du fabricant
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • Société-mère du fabricant (2017)
    Insulet Corporation
  • Source
    USFDA