BEUDAMED
    FDA Recall Terminated

    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).

    Recall: Z-1531-2013 · Initiated May 24, 2013

    Recall

    Recall Number
    Z-1531-2013
    Event Number
    65341
    Firm
    International Biomedical, Ltd.
    FEI Number
    1000058335
    Product Code
    LZF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 24, 2013
    Posted
    June 11, 2013
    Terminated
    July 29, 2013
    Address
    8508 Cross Park Dr, Austin, TX, 78754-4532

    Description

    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).

    Reason

    International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to

    Action

    International Biomedical decided to recall and sent "Product Bulletin" notification letters to their consignees on 05/24/2013 or 05/30/2013. The letter described the product issue and provided customers with recommended actions. Questions were directed to (512) 873-0033.

    Distribution

    Nationwide Distribution.

    Quantity

    7,000