GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope i

FDA device recall Z-0811-2016 · posted 2015-07-13 · Terminated

Recall details

Recalling firm

Verathon, Inc.

Reason for recall

Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.

Action taken

Verathon sent an Urgent Medical Device Safety Alert letter dated April 13, 2015 and Safety Alert Reply Form to their consignees on April 17, 2015 Users are informed that Verathon implemented a Safety Alert regarding updates to the following Operations and Maintenance Manuals (OMM): " GVL Operations and Maintenance Manual: 0900-1204-08-60 " AVL Operations and Maintenance Manual: 0900-4200-02-60 For a copy of the most recent GVL or AVL Operations and Maintenance Manual, please visit http://verathon.com/support. If you have any questions regarding the Operations and Maintenance Manuals revisions noted above, please contact your Verathon representative or Verathon Customer Care at 800.331.2313 or 425.867.1348. You may also email customerservice@verathon.com. PLEASE NOTE: NO ADDITIONAL ACTIONS NEED TO BE TAKEN.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CCW

Quantity affected

total 9088 units ( 5786 units in the US and 3302 units International)

Distribution

Worldwide Distribution.

Date initiated

2015-04-13

Date posted

2015-07-13

Date terminated

2016-10-26

Location

Bothell, WA