Events

Recall of Device Recall Sepp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 213, LLC.

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
    64585
  • Event Risk Class
    Class 3
  • Event Number
    Z-1001-2013
  • Event Initiated Date
    2013-03-04
  • Event Date Posted
    2013-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116553
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Reason
    An internal review of carefusion's labeling for preoperative skin prep product codes was recently conducted. the labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. the antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.
  • Action
    CareFusion sent an Urgent Recall Notice dated March 4, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, quarantine and return the affected product for replacement. For questions call (913) 345-3504.

Device

Device Recall Sepp
  • Model / Serial
    Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. || Product Usage: Preoperative skin product
  • Manufacturer
    CareFusion 213, LLC

Manufacturer

CareFusion 213, LLC
  • Manufacturer Address
    CareFusion 213, LLC, 1550 Northwestern Drive, El Paso TX 79912-8000
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA