Events

Recall of Device Recall Plum A3 Triple Channel Infusion Pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira 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
    63772
  • Event Risk Class
    Class 2
  • Event Number
    Z-0625-2013
  • Event Initiated Date
    2012-12-07
  • Event Date Posted
    2012-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114748
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    The door roller assembly on the plum a+/a+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the iv administration set's cassette from the pump.
  • Action
    Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters, dated December 7, 2012, to all affected customers. The letters identified the products, problem and action(s) to be taken until doors have been replaced. The customers were instructed to read the information provided carefully, including instructions to inspect the door roller assembly prior to loading a cassette for signs of damage. Customers are to complete the attached Reply Form and return it to the firm via fax at 1-877-650-8359. Customers were instructed to notify their consignees if they have further distributed the affected product. If customers require additional assistance, they are to contact Stericycle at 1-877-650-0362..

Device

Device Recall Plum A3 Triple Channel Infusion Pumps
  • Model / Serial
    list numbers 12348, 12618, and 20678; all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
  • Product Description
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA