BEUDAMED
    FDA Recall Terminated

    Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations

    Recall: Z-2133-2011 · Initiated March 24, 2011

    Recall

    Recall Number
    Z-2133-2011
    Event Number
    58278
    Firm
    Apogee Medical, Inc
    FEI Number
    3007829657
    Product Code
    OHR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2011
    Posted
    May 3, 2011
    Terminated
    February 28, 2012
    Address
    90 Weathers St., Youngsville, NC, 27596-7801

    Description

    Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations

    Reason

    Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.

    Action

    The firm, Apogee Medical LLC, sent an "Urgent Medical Device Recall" letter dated March 23, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their inventory; complete and return the enclosed Product Recall Response Form as soon as possible via fax to (919) 570-9611, mail to: Apogee Medical LLC, Youngsville Commerce Center, 90 Weathers Street, Youngsville, MC 27596, or e-mail to: [email protected]; cease further distribution and return any product that is the subject of this recall to Apogee Medical LLC. All returned product must be labeled with a returned goods authorization label that has been provided with the letter. Apogee will replace returned product upon receipt of the Product Recall Response Form and identified product. In addition, if the customer distributed the product, they are to identify their customer(s) and notify them at once of this product recall. The notification should include a copy of the this recall notification letter and should instruct the customer to return the recalled product so that it can be returned to Apogee. Should you have any questions regarding this notification, please call the Manager Regulatory Affairs/Quality Assurance at (919) 435-5409.

    Distribution

    Nationwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NJ, NY, OH, OK, TN, TX, VA and WA.

    Quantity

    5,503,430 units