Events

Recall of PORTACATH and PORTACATH II implantable venous and arterial access systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    66234
  • Event Risk Class
    Class 2
  • Event Number
    Z-2268-2013
  • Event Initiated Date
    2013-09-10
  • Event Date Posted
    2013-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121805
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Smiths medical is conducting a voluntary recall of port-a-cath¿ and port-a-cath¿ ii implantable venous and arterial access systems and introducer sets. smiths medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these sets. smiths medical has received no reports.
  • Action
    Smiths Medical ASD, Inc. sent an Urgent Field Safety Notice dated September 6, 2013, to all affected customers. The letter described the problem and the product involved in the recall. The letter included the "Advice on Action to be Taken by the User" which instructed consignees to inspect and remove affected devices and to complete and return the "Urgent Field Safety Notice Confirmation Form. The letter also included information on the "Transmission of this Urgent Field safety Notice" which included information where customers should report issues related to the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions on the information provided they should contact 800-258-5361 (Smiths Medical's Customer Service Department). For questions regarding this recall call 1-800-332-0178.

Device

PORTACATH and PORTACATH II implantable venous and arterial access systems
  • Model / Serial
    1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.
  • Product Description
    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only || PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA