Events

Rappel de Device Recall BARD Biopsy Systems

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
    64276
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1526-2013
  • Date de mise en oeuvre de l'événement
    2013-01-23
  • Date de publication de l'événement
    2013-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115745
  • 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
    Marker, radiographic, implantable - Product Code NEU
  • Cause
    Bard peripheral vascular (bpv) is initiating this recall because a combination of bard¿ ultraclip¿ dual trigger tissue marker's and support catheters (microsheath and usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
  • Action
    The firm, BARD Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter on January 23, 2013, to its customers. Bard EXPANDED its recall to include (MicroSheath and Usher support Catheters) and sent another "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 5, 2013 describing the additional products, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Do not use or further distribute any affected product; check all inventory locations within your institution; remove any identified product from your shelves and return to Bard Peripheral Vascular, Inc. 1415 W. 3rd Street, Tempe, AZ 85281; if you have further distributed any of the product, immediately contact that location and advise them of the recall and have them return to BPV; If you have used the affected product, consider notifying, educating and monitoring those affected; and complete and return the Recall and Effectiveness Check form via fax to: ATTN; Recall Coordinator in Customer Service at 1-800-994-6772, even if you no longer have possession of the product; if unable to FAX call BPV at 1-800-321-4254 Option #2 Ex 2727 and report verbally. Please call our Recall Coordinator at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at HUsilvia.carrillo@crbard.com with any questions.

Device

Device Recall BARD Biopsy Systems
  • Modèle / numéro de série
    PC 864017D; Lots: HUWK1296, HUWK1297
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
  • Description du dispositif
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. || PK4320100 Rev. 0 03/10 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Adresse du fabricant
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA