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
    80160
  • Event Risk Class
    Class 3
  • Event Number
    Z-2332-2018
  • Event Initiated Date
    2017-11-22
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164716
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    The incorrect ifu was shipped with the product.
  • Action
    The recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For further questions, please call (651) 250-4385.

Device

Device Recall ECOLAB MICROTEK Rolled Probe Cover
  • Model / Serial
    Lot numbers D151871, D151961, D161861, D162001, and D162911
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
  • Product Description
    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. || To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
  • Manufacturer
    ECOLAB INC

Manufacturer

ECOLAB INC
  • Manufacturer Address
    ECOLAB INC, 1 Ecolab Pl, Saint Paul MN 55102-2739
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    USFDA