BEUDAMED
    FDA Recall Terminated

    Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml.

    Recall: Z-0906-06 · Initiated November 29, 2005

    Recall

    Recall Number
    Z-0906-06
    Event Number
    34243
    Firm
    Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles
    FEI Number
    3002807257
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 29, 2005
    Posted
    May 25, 2006
    Terminated
    December 5, 2006
    Address
    Barcelona, CA Spain, 90032-3520

    Description

    Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml.

    Reason

    When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.

    Action

    The consignees were notified by phone beginning November 11, 2005. They were requested to return the unused product in exchange for bags from other lot numbers. The returned product will be quarantined at the warehouse. All Gri-bags from batch X-003 will be destroyed.

    Distribution

    Distributed to health care facilities in California, Georgia and Oregon.

    Quantity

    218 units, each unit contains 5 bags.