Events

Recall of KimberlyClark Single Shot Epidural Pain Management 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
    66859
  • Event Risk Class
    Class 2
  • Event Number
    Z-0518-2014
  • Event Initiated Date
    2013-10-24
  • Event Date Posted
    2013-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123803
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Reason
    Kimberly-clark single shot epidural pain management trays contain the bd 7 ml epilor plastic luer-lok lor syringes under recall by becton dickinson (bd) because the product may stall or stick when traveling within the barrel of the syringe.
  • Action
    Kimberly Clark Corporation sent a Product Advisory Notice letter to affected consignees. The letter identified the affected product, problem and actions to be taken. For questions call 770-587-8393 or via email

Device

KimberlyClark Single Shot Epidural Pain Management Trays
  • Model / Serial
    Lot numbers: 181024, 181129 181217, 181221, 181231, 182022, 182058, 182101, 182108, 182131, 182222, 182223, 182263, 182265, 182289, 182293, 182301, 182315, 181A074, 181A94, 181A154, 181A177, 181A286, 181A289, 181A369, 182A002, 182A005, 182A012, 182A055, 182A056, 182A057, 182A064, 182A074, 182A075/182A78, 182A085, 182090, 182A142, 182AA144, 182A151, 182A155, 182A178, 182A194, 182A196, 182A198, 182A202, 182A204, 182A212, 182A216 and 189A001 (syringe).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide Distribution
  • Product Description
    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) || Product Usage: || The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • Manufacturer Parent Company (2017)
    Kimberly-Clark Corporation
  • Source
    USFDA