Events

Recall of Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kimberly-Clark Corporation.

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
    35158
  • Event Risk Class
    Class 2
  • Event Number
    Z-0864-06
  • Event Initiated Date
    2006-03-15
  • Event Date Posted
    2006-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45423
  • 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
    Tubing, Fluid Delivery - Product Code FPK
  • Reason
    There exists a possibility that the pain management procedural trays may contain extension sets that do not meet usp specification requirements for non pyrogenicity (less than or equal to 2.25 eu/device (endotoxin units/device).
  • Action
    Consignees were notified via fax on/about 03/15/2006.

Device

Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays
  • Model / Serial
    Product Code: 18938, Lot #321922
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. AK, AL, CA, CO, CT, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, OK, OR, PA, TX, UT, WA, WI.
  • Product Description
    Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA. This is a Pain Management Product that is sold in a wide variety of kits including both standard tray configurations and custom kits.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA