Events

Recall of UniPerc(R) Adjustable Flange Tracheostomy Tube kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD 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
    77957
  • Event Risk Class
    Class 2
  • Event Number
    Z-3213-2017
  • Event Initiated Date
    2017-08-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158327
  • 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
    Tube tracheostomy and tube cuff - Product Code JOH
  • Reason
    Smiths medical became aware that one lot of the 8.0mm uniperc(r) adjustable flange tracheostomy tube kit, product reorder number 100/897/080 cz, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
  • Action
    Smiths Medical sent an Urgent Medical Device Recall letter dated August 7, 2017. The consignees were directed to identify the recalled product, return it to Stericycle, and respond to the recalling firm within 10 days of receipt. For further questions, please call (763) 383-3000.

Device

UniPerc(R) Adjustable Flange Tracheostomy Tube kit
  • Model / Serial
    Lot number 3308971
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
  • Product Description
    UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ || The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA