Events

Recall of Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pulsion 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
    69782
  • Event Risk Class
    Class 2
  • Event Number
    Z-1121-2015
  • Event Initiated Date
    2014-11-04
  • Event Date Posted
    2015-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131534
  • 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
    Probe, thermodilution - Product Code KRB
  • Reason
    Internal testing and investigation of the packaging revealed cracks and holes in primary packaging.
  • Action
    Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.

Device

Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit
  • Model / Serial
    Model Number PV8810US; Lot # 14AK20 and 14EK20
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
  • Product Description
    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. || Product Usage: || Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
  • Manufacturer
    Pulsion Medical Inc

Manufacturer

Pulsion Medical Inc
  • Manufacturer Address
    Pulsion Medical Inc, 3781 Attucks Dr, Powell OH 43065-6080
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA