Z-1852-2017Class II

It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2...

Name: Z-1852-2017 It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2...
Creator: Verathon Inc
Published: 2017-03-03
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2017-03-03 / Terminated / root cause: manufacturing process

FDA source

Verathon Inc began a recall of 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... on 2017-03-03. FDA classified it as Class II and gives the reason as "Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades))". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1852-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2017-04-18
Terminated: 2017-08-28
Recalling firm: Verathon Inc.
Product: 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.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Root cause tag: manufacturing process
FDA root cause: Process design
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].
Quantity in commerce: 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.
Product codes and lots: Lot GC32825

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1852-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1852-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)