Events

Recall of Device Recall iSTAT EG7 Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point of Care 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
    51211
  • Event Risk Class
    Class 3
  • Event Number
    Z-1540-2009
  • Event Initiated Date
    2009-02-23
  • Event Date Posted
    2009-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79226
  • 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
    Blood-Gases (PCO2, PO2) and Blood pH Electrode Measurement - Product Code CHL
  • Reason
    Equipment problem: i-stat cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
  • Action
    Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.

Device

Device Recall iSTAT EG7 Cartridge
  • Model / Serial
    Lot number P08274A, Box numbers: 0822, 0823, 0824, 0831, 0832, 0833, 0834, 0841, 0842, 0843, 0844, 0851, 0852, 0853, 0854, 0861, 0862, 0863, 0864, 0871, 0872, 0873, and 0874.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
  • Product Description
    i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. || Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. || Abbott Point of Care inc., Abbott Park, IL 60064 USA || Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • Manufacturer Address
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520
  • 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