BEUDAMED
    FDA Recall Terminated

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    Recall: Z-0832-2008 · Initiated December 11, 2007

    Recall

    Recall Number
    Z-0832-2008
    Event Number
    46182
    Firm
    AM2 PAT INC
    FEI Number
    3001574774
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 11, 2007
    Posted
    January 30, 2008
    Terminated
    December 2, 2010
    Address
    455 W Depot Street, Angier, NC, 27501

    Description

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    Reason

    Lack of assurance of sterility by manufacturer

    Action

    AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.

    Distribution

    Nationwide