BEUDAMED
    FDA Recall Terminated

    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.

    Recall: Z-1852-2017 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-1852-2017
    Event Number
    76642
    Firm
    Verathon Inc
    FEI Number
    3022472
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 3, 2017
    Posted
    April 18, 2017
    Terminated
    August 28, 2017
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218

    Description

    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.

    Reason

    Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).

    Action

    Verathon provided a notification letter to their Canadian distributor on March 03, 2017, and distribution of the letter to the rest-of-the-world (ROW) foreign consignees was initiated on March 10, 2017. Verathon intends to send the Urgent Medical Device Recall Glidescope GVL2 Stat letter and Customer Response Form to US consignees by March 31, 2017. Consignees should quarantine and discard any affected product on site, and fill out the attached Recall Response Form and return it to Verathon by fax to (425) 883- 2896, or email to [email protected] even if they do not have any Stats (blades) subject to the recall. Consignees who have any questions about this voluntary recall, please contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). If consignees located outside of the U.S. or Canada, please call (425) 867-1348. Consignees can also send email to [email protected].

    Distribution

    Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.

    Quantity

    Total 292 boxes (US= 254 boxes; International = 38 boxes)