BEUDAMED
    FDA Recall Terminated

    PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    Recall: Z-0721-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-0721-2008
    Event Number
    45530
    Firm
    PML, Inc. dba Pml Microbiologicals Inc.
    FEI Number
    3017344
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 15, 2007
    Posted
    February 15, 2008
    Terminated
    April 7, 2011
    Address
    27120 Sw 95th Ave P.o. Box 570, Wilsonville, OR, 97070-0570

    Description

    PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    Reason

    Incorrect micro-organism-- Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

    Action

    On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.

    Distribution

    Nationwide Distribution

    Quantity

    30 packs (each pack contains 5 vials of Haemophilus parainfluenzae)