BEUDAMED
    FDA Recall Terminated

    Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets

    Recall: Z-0097-2019 · Initiated September 7, 2018

    Recall

    Recall Number
    Z-0097-2019
    Event Number
    80945
    Firm
    Bayer Medical Care, Inc.
    FEI Number
    2520313
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 7, 2018
    Terminated
    July 11, 2019
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    Description

    Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets

    Reason

    Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.

    Action

    Urgent Medical Device Recall notification letters dated 9/7/18 were distributed to customers. The letters instruct customers to do the following: 1. Immediately discontinue use of your Intego system and quarantine the unused PAS product until further notice. 2. Contact Bayer Customer Care at 1-800-633-7231 opt. 2 or [email protected] to receive a Return Goods Authorization (RGA) number and return the Codan Filters to Bayer accordingly. 3. Complete the response form indicating if your institution does or does not have affected product. Return the form via fax (1-412-406-0942) or email ([email protected]).

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, and WI. Foreign countries: UAE, Austria, Australia, Bosnia and Herzegovina, Belgium, Bahrain, Canada, China, Chile, Costa Rica, Czechia, Denmark, German, Spain, Estonia, Egypt, Finland, France, Great Britain, Croatia, Hungary, Israel, Italy, Jordan, Kuwait, Kazakhstan, Lebanon, Lithuania, Morocco, Malta, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and Turkey

    Quantity

    1,142,836 (329,944 units in U.S.)