Events

Recall of PovidineIodine prep solution/Providine prep pads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Medical Specialties, 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
    62132
  • Event Risk Class
    Class 1
  • Event Number
    Z-2357-2012
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111524
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
  • Action
    Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.

Device

PovidineIodine prep solution/Providine prep pads
  • Model / Serial
    16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
  • Product Description
    CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution || Product Usage: Usage: || The PVP contained in the kit is used in skin prep
  • Manufacturer
    Custom Medical Specialties, Inc.

Manufacturer

Custom Medical Specialties, Inc.
  • Manufacturer Address
    Custom Medical Specialties, Inc., 330 East Main Street, Pine Level NC 27568
  • Source
    USFDA