BEUDAMED
    FDA Recall Terminated

    Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Product is manufactured and distributed by Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA

    Recall: Z-0389-06 · Initiated May 18, 2005

    Recall

    Recall Number
    Z-0389-06
    Event Number
    32077
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2005
    Posted
    January 12, 2006
    Terminated
    December 21, 2006
    Address
    755 Jarvis Dr, Morgan Hill, CA, 95037-2810

    Description

    Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Product is manufactured and distributed by Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA

    Reason

    The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.

    Action

    On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.

    Distribution

    Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.