BEUDAMED
    FDA Recall Terminated

    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

    Recall: Z-0023-2015 · Initiated August 14, 2014

    Recall

    Recall Number
    Z-0023-2015
    Event Number
    69249
    Firm
    Biomedix, Inc.
    FEI Number
    1000115518
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 14, 2014
    Posted
    October 6, 2014
    Terminated
    November 13, 2014
    Address
    3895 W Vernal Pike, Bloomington, IN, 47404-2533

    Description

    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

    Reason

    Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

    Action

    Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.

    Distribution

    US Distribution including the states of OH, NC, and TX

    Quantity

    2,928