Events

Recall of Device Recall Bard Monopty Disposable Core Biopsy Instruments and Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70733
  • Event Risk Class
    Class 2
  • Event Number
    Z-1447-2015
  • Event Initiated Date
    2015-03-17
  • Event Date Posted
    2015-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134572
  • Notes / Alerts
    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.
  • Extra notes in the data
    Instrument, biopsy - Product Code KNW
  • Reason
    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
  • Model / Serial
    Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
  • Product Description
    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
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA