Events

Recall of Device Recall Microcuff

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

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
    38226
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2007
  • Event Initiated Date
    2007-06-04
  • Event Date Posted
    2007-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53193
  • 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
    Endotracheal Tube - Product Code BTR
  • Reason
    The tubes may kink during use which may impede or prevent ventilation.
  • Action
    Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.

Device

Device Recall Microcuff
  • Model / Serial
    Product code 35111-07, 35112-07, 35113-07 and 35114-07, All Lots.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
  • Product Description
    Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA