BEUDAMED
    FDA Recall Terminated

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    Recall: Z-1974-2020 · Initiated April 23, 2020

    Recall

    Recall Number
    Z-1974-2020
    Event Number
    85586
    Firm
    Access Scientific LLC
    FEI Number
    3009549229
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 23, 2020
    Posted
    May 14, 2020
    Terminated
    April 27, 2021
    Address
    3910 Sorrento Valley Blvd, Ste 200, San Diego, CA, 92121-1419

    Description

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    Reason

    Saline Flush Syringe compromised sterility due to holes in the packaging.

    Action

    Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits.

    Distribution

    US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.

    Quantity

    7,395 units