BEUDAMED
    FDA Recall Terminated

    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.

    Recall: Z-1536-2015 · Initiated April 17, 2014

    Recall

    Recall Number
    Z-1536-2015
    Event Number
    70641
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 17, 2014
    Posted
    April 27, 2015
    Terminated
    July 21, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.

    Reason

    Potential for device malfunction resulting in flow when the device should not be flowing

    Action

    Baxter Healthcare sent an Urgent Product Recall letter dated April 17, 2014, to the sole US consignee. The letter included instructions for the consignee to: 1) locate and remove all affected product; 2) contact Baxter's Center for Service to arrange for the return and credit; and 3) to complete and return the Customer Reply Form included with the recall notification. Questions about the recall can be answered by calling The Center for One Baxter at 800-422-9837.

    Distribution

    Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.

    Quantity

    7,596 patient control modules