Events

Recall of Device Recall Deltec CADDPrizm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deltec, 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
    26550
  • Event Risk Class
    Class 2
  • Event Number
    Z-0980-03
  • Event Initiated Date
    2003-06-23
  • Event Date Posted
    2003-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27876
  • 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
    Pump, Infusion - Product Code FRN
  • Reason
    Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
  • Action
    A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.

Device

Device Recall Deltec CADDPrizm
  • Model / Serial
    Pump Serial numbers 658825, 658837, 658840, 658842, 658844 - 658865, 658867, 658869 - 658896, 658898 - 658918, 658920 - 658936, 658941, 658943 - 658947, 658949, 662473 - 662477, 662483, 662485, 662488 - 662490, and 662635 - 662659
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
  • Product Description
    Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
  • Manufacturer
    Deltec, Inc

Manufacturer

Deltec, Inc
  • Manufacturer Address
    Deltec, Inc, 1265 Grey Fox Road, St Paul MN 55112
  • Source
    USFDA