Events

Rappel de Device Recall Halo One ThinWalled Guiding Sheath

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 BARD PERIPHERAL VASCULAR, 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
    75875
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0970-2017
  • Date de mise en oeuvre de l'événement
    2016-12-02
  • Date de publication de l'événement
    2017-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151513
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Complaints of sheath separation, kinking, and/or tip damage during use.
  • Action
    Bard sent an Urgent Medical Device Recall Notification letter dated December 2, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to find attached instructions detailing the steps they need to take regarding the product. Customers with questions were instructed to contact their Bard representative. Customers were provided the following instructions: 1. Records show that your facility has purchased product codes affected by this voluntary recall. Do not use or further distribute any affected product. 2. Check all inventory locations within your institution for affected product code / lot number combination listed in the recall notice. If have further distributed any of the product code / lot numbers, immediately contact that location, advise them of the recall, forward instructions and have them return the affected product to BPV. 3. Remove any identified product from shelves. 4. If have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that intend to return. It is extremely important that this information is received . 6. Please call the firm's Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Once all information has been verified, the Recall Coordinator will issue you either a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will issue a credit for returned product. Email the completed Recall and Effectiveness Check Form to HaloOneRecall@crbard.com or fax it to BPV at 1-800-994-6772. If cannot email or FAX the form, please call the BPV recall coordinator at 1-8

Device

Device Recall Halo One ThinWalled Guiding Sheath
  • Modèle / numéro de série
    Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
  • Description du dispositif
    Halo One 5F Introducer Sheath 10 cm 5 pack || Product Code: HAL510F || Product Usage: || The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
  • Manufacturer
    BARD PERIPHERAL VASCULAR, INC

Manufacturer

BARD PERIPHERAL VASCULAR, INC
  • Adresse du fabricant
    BARD PERIPHERAL VASCULAR, INC, 1415 W 3rd St, Tempe AZ 85281-7634
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA