Events

Recall of Device Recall LifeShield HemoSet I.V. PlumSet

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
    67722
  • Event Risk Class
    Class 2
  • Event Number
    Z-1479-2014
  • Event Initiated Date
    2014-02-25
  • Event Date Posted
    2014-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126148
  • 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
    Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a hemoset containing a burette and blood filter, intended for infusion of blood/blood products. in a gravity delivery, the correct lower lid dispenses 15 drops per ml and the incorrect lower lid found dispenses 10 drops per ml.
  • Action
    Hospira sent a URGENT MEDICAL DEVICE RECALL letter dated February 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) check their inventory and immediately quarantine any affected product; 2) complete the attached reply form and return it to the fax number or e-mail address on the form; 3) inform potential users within the direct account's organization of this product of the recall; 4) return affected products to Stericycle using labels provided with the notification; and 5) follow the instructions on the return label for returning products. Additional labels and guidance on returning products can be obtained by calling Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET). If the recalled products were further distributed, the recall notification documents should be forwarded to those accounts. Those accounts can contact Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain a reply form and guidance on the return process.

Device

Device Recall LifeShield HemoSet I.V. PlumSet
  • Model / Serial
    Product List Number: 112410403; Lot Numbers: 280055H, 341005H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
  • Product Description
    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. || For administration of blood and blood bags for use with Plum Series Infusers.
  • 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