Events

Recall of Device Recall Ecolab, Microtek Rolled Probe Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ecolab 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
    75826
  • Event Risk Class
    Class 3
  • Event Number
    Z-0753-2017
  • Event Initiated Date
    2016-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151425
  • 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
    Drape, surgical - Product Code KKX
  • Reason
    The reason for the recall is that the inner carton box of the rolled probe cover pc0907nb has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). the manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
  • Action
    Ecolab sent an "Urgent Medical Device Recall" letter dated November 30, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to quarantine the product for return. If the product was further distributed notify them of the recall. Requested customers to complete and return the Recall Response Form. For questions contact Customer Service by phone at 1-800-824-3027 or e-mail customerservice@microtekmed.com. For further questions please call (651) 250-4385.

Device

Device Recall Ecolab, Microtek Rolled Probe Cover
  • Model / Serial
    15302
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..
  • Product Description
    Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
  • Manufacturer
    Ecolab Inc

Manufacturer

Ecolab Inc
  • Manufacturer Address
    Ecolab Inc, 370 Wabasha St N, Saint Paul MN 55102-1323
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    USFDA