Events

Recall of Transpac IV Monitoring Kit

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
    75491
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2017
  • Event Date Posted
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150543
  • 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
    ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were 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 2, or e-mail the following address: productreturns@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. Customers with questions were instructed to call 866-829-9025.

Device

Transpac IV Monitoring Kit
  • Model / Serial
    3265488
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 || 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