BEUDAMED
    FDA Recall Terminated

    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

    Recall: Z-0365-2020 · Initiated May 10, 2019

    Recall

    Recall Number
    Z-0365-2020
    Event Number
    83867
    Firm
    Cadence Science, Inc.
    FEI Number
    1213649
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 10, 2019
    Terminated
    June 5, 2020
    Address
    2080 Plainfield Pike, Cranston, RI, 02921-2012

    Description

    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

    Reason

    The glass syringe used with Pressure Control Syringes may potentially break during use.

    Action

    On May 10, 2019, the firm distributed Advisory Notice letters to affected customers. Customers were advised of the potential issue involving breakage of the glass syringe used with Pressure Control Syringes. The firm recommended that the customer inspect the product for this issue prior to use in accordance with the Instructions For Use (IFU) which were provided with the product. The firm provided an additional IFU with the notification. Upon successful inspection, the firm recommended that customers continue to use the product in accordance with the IFU and continue to follow all OSHA recommendations for the safe handling of chemicals to include PPE. Customers may contact Chuck Funkhouser at 401-942-1031, ext. 4226 or [email protected], or Jeff Crist at 540-245-1022 or [email protected] with any questions.

    Distribution

    US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.

    Quantity

    237