Events

Recall of Device Recall Transpac Trifurcated monitoring kit with Safeset Reservoir

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
    68971
  • Event Risk Class
    Class 2
  • Event Number
    Z-2162-2014
  • Event Initiated Date
    2014-07-18
  • Event Date Posted
    2014-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129168
  • 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 has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
  • Action
    ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.

Device

Device Recall Transpac Trifurcated monitoring kit with Safeset Reservoir
  • Model / Serial
    Lot No. 2841690, 2841691, 2859331
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Oregon and Internationally to Australia.
  • Product Description
    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 || Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
  • 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