U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Laryngoscope, rigid - Product Code CCW
원인
Product labeled as gvl 2 stat (blades), lot gc32825, was physically packaged with the incorrect size device (gvl 1 stat (blades)).
조치
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 CSNotifications@verathon.com 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 cservice@verathon.com.
Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
제품 설명
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.