Events

Recall of Device Recall Microtek Angiography Drape with Radiation Shield

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
    74710
  • Event Risk Class
    Class 2
  • Event Number
    Z-2744-2016
  • Event Initiated Date
    2016-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148264
  • 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
    Ecolab is recalling 2 models of angiography drapes with radiation shields because the sterile packaging may contain small holes in the film of the pouch.
  • Action
    Consignees were sent on 7/14/2016 an Ecolab "Urgent Medical Device Recall" letter dated July 14, 2016. The letter described the problem and the product involved in the recall. Advised consignees to immediately quarantine the product and to notify their customers. For questions contact Customer Service at 1-800-824-3027.

Device

Device Recall Microtek Angiography Drape with Radiation Shield
  • Model / Serial
    RBA202 Lot numbers: D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, D160544.   RBA203 Lot numbers: D122194, D122354
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: OH, NY, CA, MN.
  • Product Description
    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
  • 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