BEUDAMED
    FDA Recall Terminated

    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

    Recall: Z-3203-2018 · Initiated July 11, 2018

    Recall

    Recall Number
    Z-3203-2018
    Event Number
    80747
    Firm
    COVIDIEN LLC
    FEI Number
    1282497
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2018
    Terminated
    August 3, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

    Reason

    The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

    Action

    On 7/11/18, an Urgent Medical Device Recall letter was distributed to customers. The letter instructed customers to do the following: 1. Please quarantine any unused product of the Covidien item codes and lot numbers listed above (see Attachment A to locate). 2. If you have distributed any of the affected Covidien catheters or kits, then please promptly forward a copy of this letter to those recipients. 3. All unused product of affected item codes and lot numbers must be returned. 4. Please return unused affected product as explained below. You must complete the Recalled Product Return Form (Attachment B) regardless of whether or not you have inventory of affected product.

    Distribution

    The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.

    Quantity

    27515 total