BEUDAMED
    FDA Recall Terminated

    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

    Recall: Z-2065-2020 · Initiated April 16, 2020

    Recall

    Recall Number
    Z-2065-2020
    Event Number
    85432
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 16, 2020
    Terminated
    September 1, 2021
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

    Reason

    This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

    Action

    On April 16, 2020, the firm initiated customer notification via Urgent Medical Device Recall letters. Customers were informed that the product had been confirmed to exhibit holes in the packaging, potentially compromising a sterile field. Customers were asked to do the following: 1. Immediately review your inventory for the catalog and lot numbers specified in this notification and discard all product subject to the recall. 2. Share this recall notification with any users of the product, within your facilities, to ensure they are also aware of this recall. 3. Complete and return the attached Customer Response Form, to the contact on the form confirming acknowledgement of the notification and request replacement for all discarded product. 4. Report any adverse health consequences experienced with the use of this product to BD. Actions Taken by BD: 1. Corrective actions have been implemented at the manufacturing site to address this issue. 2. As BD is currently experiencing backorders for this product due to increased demand, they are maximizing production to help reduce the impact to customers. 3. BD will work diligently to prioritize the replacement of product to customers affected by the recall. Please complete the Customer Response Form to assure BD is aware of your replacement needs. If you have questions about this recall, you may reach BD Regional Customer Quality at 888-237-2762 OPT 4, OPT 2; Monday through Friday, between 8AM and 5PM (CT).

    Distribution

    Nationwide domestic distribution. Foreign distribution to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, New Zealand

    Quantity

    16,099,310 units