Events

Recall of Double Kit with SafeSet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ICU Medical, 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
    74966
  • Event Risk Class
    Class 2
  • Event Number
    Z-2817-2016
  • Event Initiated Date
    2016-08-10
  • Event Date Posted
    2016-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148921
  • 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
    Transducer, Blood-Pressure, Extravascular - Product Code DRS
  • Reason
    Icu medical inc. has identified a potential for leak with certain safeset reservoir and blood sampling kits containing the transpac iv transducers.
  • Action
    An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com.

Device

Double Kit with SafeSet
  • Model / Serial
    lot number 3274859
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 || Product Usage: || The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA