Events

Rappel de Device Recall Bard Monopty Disposable Core Biopsy Instruments and Kits

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
    70733
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1447-2015
  • Date de mise en oeuvre de l'événement
    2015-03-17
  • Date de publication de l'événement
    2015-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134572
  • 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
    Instrument, biopsy - Product Code KNW
  • Cause
    Bard peripheral vascular is recalling the bard monopty disposable core biopsy instruments and kits because they may be at risk of having activation-related issues.
  • Action
    The firm, Bard Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/17/15 to customers. The letter informs customers of the problems identified and the actions to be taken. The customers were instructed to do the following: Do not use or further distribute any affected product; check all inventory locations within your institution; if you have further distributed any of the product, advise them of the recall and have them return the affected product to BPV; remove any idenfied product from your shelves; and complete and return the attached Recall and Effectiveness Check Form to BPV by fax at (800) 994-6772, if you cannot FAX the form, call the BPV telephone number provided on the form and report the required information verbally. BPV will provide replacement product for your returned product. Customers are instructed to call BPV's Recall Coordinator at 1-800-321-4254 Option #2 Ext 2988 (M-F 7am to 4pm MST) or email at HUrandy.hopkins@crbard.comUH.

Device

Device Recall Bard Monopty Disposable Core Biopsy Instruments and Kits
  • Modèle / numéro de série
    Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
  • Description du dispositif
    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. || The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
  • 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