The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED

FDA device recall Z-0478-2013 · posted 2012-12-07 · Terminated

Recall details

Recalling firm

Verathon, Inc.

Reason for recall

Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.

Action taken

The firm, Verathon, sent an "URGENT - Medical Device Recall" letter dated October 25, 2012, to their consignees/cutomers. The letter described the product, problem, and actions to be taken. The customers were instructed to return the recalled blades back to Verathon and complete and return the Device Recall Notification Reply Form via fax to (425) 883-2896 or email: cservice@verathon.com. All returned products will be quarantined and will be destroyed later. Verathon will replace the affected video laryngoscope blade at no cost to customers. Customers in Canada and US with questions can call 800-331-2313. If you are located outside of the US or Canada, please call 425-867-1348.

Root cause

Device Design

Status

Terminated

Product code

CCW

Quantity affected

total 2710 units

Distribution

Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR

Date initiated

2012-10-25

Date posted

2012-12-07

Date terminated

2013-09-27

Location

Bothell, WA