Events

Recall of Personal Intermittent Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, 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
    78642
  • Event Risk Class
    Class 2
  • Event Number
    Z-1309-2018
  • Event Initiated Date
    2017-09-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161606
  • 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
    Catheter, straight - Product Code EZD
  • Reason
    Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Device

Personal Intermittent Catheters
  • Model / Serial
    Catalog numbers: 50612, 50614, 50616, 50618, 52308, 52310, 52606, 52608, 52608G, 52610, 52610G, 53314, 53320, 53610G, 53612G, 53614G, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 71410, 71412, 71618, 72608, 72610, 73612, 73614, and 73616
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Hawaii and Puerto Rico
  • Product Description
    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. || Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA