BEUDAMED
    FDA Recall Terminated

    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.

    Recall: Z-1526-06 · Initiated March 24, 2006

    Recall

    Recall Number
    Z-1526-06
    Event Number
    36130
    Firm
    Ogenix Corporation
    FEI Number
    3004036118
    Product Code
    KPJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2006
    Posted
    September 28, 2006
    Terminated
    December 19, 2007
    Address
    23230 Chagrin Blvd, Suite 950, Cleveland, OH, 44122-5461

    Description

    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.

    Reason

    Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.

    Action

    Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.

    Distribution

    The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.

    Quantity

    518