BEUDAMED
    FDA Recall Terminated

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    Recall: Z-0119-2019 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-0119-2019
    Event Number
    81113
    Firm
    Cypress Medical Products LLC
    FEI Number
    1451040
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 4, 2018
    Terminated
    May 28, 2024
    Address
    9954 Mayland Dr, Richmond, VA, 23233-1464

    Description

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    Reason

    Small hole at the end of the syringe is impeding suction of liquid.

    Action

    Cypress Medical Products LLC notified the distributor, McKesson Medical-Surgical, on 9/4/18. McKesson Medical-Surgical is responsible for communications to the distribution centers and end users. Any material on hand at end user facilities will be returned to the McKesson DC. Accounts requested to cease distribution and quarantine product for return. A response form included with letter to be completed and returned.

    Distribution

    US Nationwide Distribution

    Quantity

    400 cases