BEUDAMED
    FDA Recall Terminated

    SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath Set,acc CH12 Male,bul 280320 1400 SureCath Set,acc CH14 Male 28032S 1400 Surecath Set,acc CH14 Male,bul 28036S 1400 Surecath Set,acc CH14/1,2 Male 28037S 1400 Surecath Set,acc CH16 Male 280370 1400 Surecath Set,acc CH16 Male 28033S 1400 Surecath Set,acc CH16 Male 280360 1400 Surecath Set,acc CH14/1,2 Male 280340 1400 SURECATH SET W.ACC FEM14` The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.

    Recall: Z-2409-2011 · Initiated April 21, 2011

    Recall

    Recall Number
    Z-2409-2011
    Event Number
    58681
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    EZD
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    April 21, 2011
    Posted
    June 3, 2011
    Terminated
    April 24, 2012
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath Set,acc CH12 Male,bul 280320 1400 SureCath Set,acc CH14 Male 28032S 1400 Surecath Set,acc CH14 Male,bul 28036S 1400 Surecath Set,acc CH14/1,2 Male 28037S 1400 Surecath Set,acc CH16 Male 280370 1400 Surecath Set,acc CH16 Male 28033S 1400 Surecath Set,acc CH16 Male 280360 1400 Surecath Set,acc CH14/1,2 Male 280340 1400 SURECATH SET W.ACC FEM14` The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.

    Reason

    Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i

    Action

    Coloplast Manufacturing US, LLC sent a Coloplast "Product Field Correction Notice" dated April 21, 2011. The letter was addressed to "Dear Valued Customer". The letter described the problem and the product involved in the recall. Customers were advised to provide the current inventory levels of the lots affected and the firm will be providing them with new iodine prep pads with sufficient shelf life. This product will include customer instructions, informing the customer to discard the original prep pads and use the new prep pads instead. If they prefer, they could themselves send the affected product back to Coloplast and they in return will attach new prep pads to the product for them. If they have further distributed the product, they advised consignees to contact their customers and to include the letter provided to them to inform them of the recall.

    Distribution

    Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.

    Quantity

    438,412