Events

Recall of Device Recall CVS Brand

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

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
    28079
  • Event Risk Class
    Class 2
  • Event Number
    Z-0379-04
  • Event Initiated Date
    2003-11-20
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31157
  • 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
    Accessories, Solution, Ultrasonic Cleaners For Lenses - Product Code LYL
  • Reason
    Product label fails to provide adequate warning for use.
  • Action
    CVS issued a product recall on 11/19/03, from the Category Manager to Store Operations for the product to be removed from retail stores. The request listed Item # 191648, CVS One-Step Disinfecting Solution, 12 fl. oz., all lot #''s,.Individual pieces (bottles) would be returned through a third party, Carolina Logistics. An e-mail was also sent on 11/19/03 from the Quality Assurance Department to the nine CVS distribution centers requesting item # 191648 be removed from its pick line location as well as any other warehouse locations and be put on quality hold. Each distribution center was asked to return the amount of product on hand at that particular center to the quality assurance department. The product was removed from sale from the CVS.com website.

Device

Device Recall CVS Brand
  • Model / Serial
    All lot codes
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). || [OTC] || Item Number: 191648
  • Manufacturer
    CVS

Manufacturer

CVS
  • Manufacturer Address
    CVS, 1 CVS Drive, Woonsocket RI 02895-6146
  • Source
    USFDA