Events

Recall of Sterile Empty Vial and Injector (30mL PCA vial),

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
    62909
  • Event Risk Class
    Class 2
  • Event Number
    Z-2346-2012
  • Event Initiated Date
    2012-08-02
  • Event Date Posted
    2012-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112021
  • 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
    Reports of leaking during filling and administration.
  • Action
    Hospira sent an Urgent Device Field Correction letter dated August 3, 2012, to all affected customers. The letter identifed the product, the probem, and the action to be taken by the customer. Customers were instructed to first consider the use of Prefilled Morphine PCA Vials wherever possible. In some instances, the treating physician may require an alternative to morphine. Customers may continue using the affected product by following the instructions provided in the Correction Letter. Customers were asked to complete the attached Reply Form and fax it to 1-888-879-8144. For questions regarding this recall call 877-946-7747.

Device

Sterile Empty Vial and Injector (30mL PCA vial),
  • Model / Serial
    The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.
  • Product Description
    Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. || For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
  • Manufacturer
    Hospira, Inc.

Manufacturer

Hospira, Inc.
  • Manufacturer Address
    Hospira, Inc., 600 N Field Dr Bldg J45, Lake Forest IL 60045
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA