Events

Recall of Device Recall LifeCare PCA 3

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
    64225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1517-2015
  • Event Initiated Date
    2013-02-27
  • Event Date Posted
    2015-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115634
  • 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, pca - Product Code MEA
  • Reason
    The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. this in turn permits unauthorized access to the vial of medication.
  • Action
    Hospira will contract with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by the UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified the users. For questions regarding this recall call 800-441-4100.

Device

Device Recall LifeCare PCA 3
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico, American Virgin Islands; and Internationally to Canada.
  • Product Description
    The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
  • 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