Events

Recall of Device Recall CaviWipes1 Extra Large

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Metrex Research, 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
    76318
  • Event Risk Class
    Class 2
  • Event Number
    Z-1402-2017
  • Event Initiated Date
    2017-01-20
  • Event Date Posted
    2017-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152763
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • Reason
    Metrex is recalling the caviwipes extra large because they may have been contaminated during the packaging process.
  • Action
    Metrex sent an Urgent Medical Device Recall letter dated January 20, 2017, to all affected customers to inform them that Metrex is recalling one lot of CaviWipes Extra Large because they may have been contaminated during the packaging process. Customers were informed that while handling sealed containers, a production worker sustained a minor finger cut which may have come in contact with the exterior surface of the container. Customers were instructed to contact Metrex Customer care at (800) 537-7123 to receive a RMA number. The RMA will allow for a quick return and replacement or credit. Customers were instructed to identify any customers that may have been shipped the affected product and contact their customers using the customer notification letter that Metrex issued. Metrex requests that those customers contact Metrex Customer Care at (800) 537-7123 and complete the attached acknowledgement form. For questions regarding this recall call 734-947-6700.

Device

Device Recall CaviWipes1 Extra Large
  • Model / Serial
    Lot No. 16-2340PA
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
  • Product Description
    CaviWipes1 Extra Large, Part No. 13-5150 || The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
  • Manufacturer
    Metrex Research, LLC.

Manufacturer

Metrex Research, LLC.
  • Manufacturer Address
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA