Retiro De Equipo (Recall) de Device Recall GlideScope Titanium SingleUse Video Laryngoscope

Recall

73014

Class 1

Z-1035-2016

2016-01-29

2016-03-11

Terminated

United States

2017-03-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142740

The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when glidescope titanium su laryngoscope blades are in use. video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.

The firm, Verathon, began mailing the "URGENT: MEDICAL DEVICE RECALL" GLIDESCOPE VIDEO LARYNGOSCOPE TITANIUM SINGLE-USE BLADES letter to their consignees on January 29, 2016. The letter describes the product, problem and actions to be taken. Verathon will instruct the company's foreign distributors to communicate the Customer Recall Letter to their international customers. Verathon has contracted with a business services company, Stericycle, to coordinate the initial consignee communications in the United States, Australia and Canada. Stericycle will send the Customer Recall Letters, and conduct consignee follow-up communications for return of the Recall Response Forms. Verathon will replace all affected GlideScope Titanium Single Use (SU) blades that remain in your facility's inventory with new product that has been passed the enhanced screening test for video flickering. Customers were advised to take the following actions: -Fill out the attached Recall Response Form and return it to Verathon by fax (888) 943-5170, or email, verathon5165@stericycle.com. Please return the form even if you do not have any blades subject to the recall. If consignees need to expedite a product replacement contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). The firm has live agent support Monday through Friday from 8:00am to 5:00pm Eastern Time. Consignees can also send email to CCTechSupport@verathon.com. Consignees who have any questions about this Product Recall, please contact Verathon representative or call (888) 943-4207 (U.S. and Canada) or send email to verathon5165@stericycle.com. Please report any suspected malfunction or adverse event related to any GlideScope Video Laryngoscope devices to Verathon Customer Care at the telephone numbers above and to FDA's MedWatch Program (1-800-FDA-1088 or www.fda.gov/medwatch).