Events

Recall of PVP Prep Solution

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
    62875
  • Event Risk Class
    Class 2
  • Event Number
    Z-2331-2012
  • Event Date Posted
    2012-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111924
  • 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
    Tray, surgical - Product Code LRP
  • Reason
    The firm saw on the fda web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
  • Action
    Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (919) 202-8462, ext 205 to obtain a Return Authorization Number and the shipping number. For questions regarding this recall call 919-202-8462.

Device

PVP Prep Solution
  • Model / Serial
    14327-0902, 19929-1006
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including GA, MI, NY, and PA.
  • Product Description
    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution || CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
  • 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