BEUDAMED
    FDA Recall Open, Classified

    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

    Recall: Z-2537-2021 · Initiated August 5, 2021

    Recall

    Recall Number
    Z-2537-2021
    Event Number
    88499
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    EZL
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    August 5, 2021
    Posted
    September 23, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

    Reason

    There is potential for packaging defects that may impact the sterile barrier.

    Action

    Customer letters were sent "URGENT MEDICAL DEVICE RECALL" via FedEx and email to affected consignees on August 13, 2021. Customers are asked to please Take the Following Actions: 1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers. 2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice. 4. If you purchased this product from a distributor, contact your distributor for further instructions. 5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit. 6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program BD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form. BD has implemented actions to prevent recurrence of this product issue. The firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.

    Distribution

    US Nationwide distribution.

    Quantity

    40 units