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

FDA device recall Z-1852-2017 · posted 2017-04-18 · Terminated

Recall details

Recalling firm

Verathon Inc

Reason for recall

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

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

CCW

Quantity affected

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

Distribution

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

Date initiated

2017-03-03

Date posted

2017-04-18

Date terminated

2017-08-28

Location

Bothell, WA