BEUDAMED
    FDA Recall Terminated

    ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

    Recall: Z-1904-2009 · Initiated July 10, 2009

    Recall

    Recall Number
    Z-1904-2009
    Event Number
    52725
    Firm
    Memphis Fertility Laboratory Inc
    FEI Number
    3005682148
    Product Code
    NUC
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 10, 2009
    Posted
    August 27, 2009
    Terminated
    October 5, 2009
    Address
    80 Humphreys Center Drive, Suite 307, Memphis, TN, 38120-2363

    Description

    ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

    Reason

    Product was marketed without a 510(k).

    Action

    The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.

    Distribution

    Nationwide Distribution -- USA, including the state of MA.

    Quantity

    800 units