Events

Recall of Device Recall CADD Administration Set, 21733924, Rx Only, Sterile EO.

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
    76749
  • Event Risk Class
    Class 2
  • Event Number
    Z-1767-2017
  • Event Initiated Date
    2017-03-17
  • Event Date Posted
    2017-03-30
  • 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=154083
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Smiths medical has become aware that the drawing on the instructions for use (ifu) on certain yellow striped cadd¿ administration sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. although the text description on the ifu correctly identifies the product to include a 0.2 micron filter, the illustration on the ifu identifies the filter size as 2.0 microns.
  • Action
    Smiths Medical sent an "Urgent Medical Device Field Safety Notice" dated March 13, 2017. The letter was addressed to "Risk Manager". It provided a list of the Affected devices, Risk to Health, Instructions to Distributors & Customers. Advised consignees to notify their customers. There is no need to return the devices to Smiths Medical. Requested consignees to complete the Urgent Medical Device Field Safety Notice (FSN) Response Form and return to smithsmedical3947@stericycle.com. For questions contact Stericycle at 844-265-7407. For further questions regarding this recall , please call (844) 265-7407.

Device

Device Recall CADD Administration Set, 21733924, Rx Only, Sterile EO.
  • Model / Serial
    46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US:AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY. OUS: Canada
  • Product Description
    CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
  • 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