BEUDAMED
    FDA Recall Terminated

    Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.

    Recall: Z-1318-04 · Initiated July 2, 2004

    Recall

    Recall Number
    Z-1318-04
    Event Number
    29531
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 2, 2004
    Posted
    August 7, 2004
    Terminated
    December 21, 2004
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.

    Reason

    Sheep Blood products may be contaminated with a Brucella species (B. ovis).

    Action

    Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail. Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04). Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return. Response forms will be reconciled. Distribution of the affected lots ceased on 7/1/04. Customers are asked to discard their inventory.

    Distribution

    83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

    Quantity

    2 vials