BEUDAMED
    FDA Recall Terminated

    B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926

    Recall: Z-0586-06 · Initiated February 6, 2006

    Recall

    Recall Number
    Z-0586-06
    Event Number
    34598
    Firm
    B. Braun Medical Inc
    FEI Number
    2021236
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2006
    Posted
    March 3, 2006
    Terminated
    May 28, 2008
    Address
    2525 McGaw Ave, Irvine, CA, 92614-5841

    Description

    B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926

    Reason

    B. Braun Medical has been notified by the manufacturer of the product (Stedim) that a small percentage of the lots leak from the set port when the set port is opened. The leak was identified by Stedim to be due to the incorrect placement of a septum in the set port. The set closure is intact and the leak remains internal until the set port is opened.

    Action

    A recall notification letter was sent to the 22 customers who received the product between 12/1/05 and 1/11/06. The recall packages included a letter addressed to either the Director of Pharmacy/Director of Nursing, Materials Manager, or Distributor, as appropriate. They were mailed via US Post Office certified return receipt mail. Customers were instructed by letter to return all product at their facility to B. Braun Medical, Inc. in Breinigsville Pennsylvania. A Recall Information Form and a postage paid B. Braun Medical, Inc. return envelope were included in the recall package for the customer''s use.

    Distribution

    Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX

    Quantity

    13,480