BEUDAMED
    FDA Recall Terminated

    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R

    Recall: Z-1543-05 · Initiated February 25, 2005

    Recall

    Recall Number
    Z-1543-05
    Event Number
    31188
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 25, 2005
    Posted
    September 23, 2005
    Terminated
    February 16, 2011
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R

    Reason

    Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.

    Action

    Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries from overcurrent damage and swelling during charging, and advised them of the availability of the battery harness. The letters also provided information to prevent excessive discharge, and advised them that software updates will become available later in 2005. An Operator's Manual Addendum was also included with the 2/25/05 letter, replacing chapter 7 of the manual dealing with Maintenance and Service. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.

    Distribution

    Nationwide including Puerto Rico, and internationally to Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia.

    Quantity

    152,260 pumps