BEUDAMED
    FDA Recall Completed

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    Recall: Z-0085-2018 · Initiated October 18, 2017

    Recall

    Recall Number
    Z-0085-2018
    Event Number
    78375
    Firm
    Bioseal Corporation
    FEI Number
    2027062
    Product Code
    KDD
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 18, 2017
    Address
    167 W Orangethorpe Ave, Placentia, CA, 92870-6922

    Description

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    Reason

    Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

    Action

    The firm initiated the recall by letter on 10/18/2017. The letter requested the consignee discontinue use of the product and notify the recalling firm with the quantities on hand for return. Those consignee who further distributed the product were directed to notify their customers and have the affected products returned to them for return to Bioseal.

    Distribution

    CA, IL, NC, VT

    Quantity

    51635 units