BEUDAMED
    FDA Recall Open, Classified

    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139018-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139021-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139022-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138975-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 138976-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138977-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 BD PYXIS MEDBANK TWR MN CR-14HH-P 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139085-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138964-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138965-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138970-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P

    Recall: Z-1227-2025 · Initiated January 8, 2025

    Recall

    Recall Number
    Z-1227-2025
    Event Number
    96124
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 8, 2025
    Posted
    February 21, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139018-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139021-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139022-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138975-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 138976-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138977-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 BD PYXIS MEDBANK TWR MN CR-14HH-P 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139085-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138964-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138965-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138970-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P

    Reason

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Action

    On January 8, 2025, CareFusion 303 issued a "Urgent: Medical Device Correction" Notification to affected customer via mail or Email. CareFusion asked consignees to take the following actions: 1. Customers should immediately ensure that MedBank" devices are not installed in the procedural or operating space and at least 1.5 meters from patients. 2. Report any issues associated with the above products to BD Pyxis" MedBank" Product Support Line via phone at 866-930-9251. 3. Report any adverse health consequences experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. 4. Please post these notices with the device until labeling has been updated. 5. Complete the attached Customer Response Form and return to BD.

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    6,075 units