Events

Recall of Device Recall Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories.

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
    48725
  • Event Risk Class
    Class 2
  • Event Number
    Z-2305-2008
  • Event Initiated Date
    2008-06-27
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72003
  • 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
    Infusion pump - Product Code LZH
  • Reason
    Product was incorrectly labeled as "top-fill enteral nutrition bag" instead of "flexiflo quantum pump set.".
  • Action
    On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance.

Device

Device Recall Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag
  • Model / Serial
    List #50604 Lot #47822RY Use By DEC 2009
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY.
  • Product Description
    Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag || The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 625 Cleveland Ave, Columbus OH 43215-1754
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA