BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1540-2009 · Initiated February 23, 2009

    Recall

    Recall Number
    Z-1540-2009
    Event Number
    51211
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 23, 2009
    Posted
    June 18, 2009
    Terminated
    July 29, 2009
    Address
    104 Windsor Center Dr, East Windsor, NJ, 08520

    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.

    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.

    Distribution

    Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.

    Quantity

    1048 boxes of 25 cartridges each.