Z-0420-2016 Class II Terminated

Recalled by Verathon, Inc. — Bothell, WA

Recall Details

Product Type
Devices
Report Date
December 23, 2015
Initiation Date
November 30, 2015
Termination Date
August 22, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
total 612 units (394 units in the US and 218 units outside the US)

Product Description

GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.

Reason for Recall

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Distribution Pattern

Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.

Code Information

***ADDITIONAL 72 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15 *** LG151991, LG152083, LG152084, LG152180, LG152181, LG152183, LG152184, LG152185, LG152186, LG152187, LG152188, LG152189, LG152191, LG152192, LG152193, LG152194, LG152195, LG152196, LG152197, LG152198, LG152199, LG152201, LG152202, LG152203, LG152204, LG152205, LG152206, LG152207, LG152208, LG152209, LG152210, LG152216, LG152217, LG152218, LG152219, LG152220, LG152221, LG152222, LG152223, LG152224, LG152225, LG152226, MD151720, MD151835, MD151879, MD151880, MD151881, MD151882, MD151883, MD151885, MD151886, MD151887, MD151888, MD151891, MD151895, MD151896, MD151897, MD151898, MD151900, MD151901, MD151902, MD151903, MD151904, MD151921, MD151923, MD151924, MD151925, MD151926, MD151927, MD151928, XL151554, and XL151569. ****SERIAL NUMBERS OF UNITS IN THE US***************************************** LG151858, LG151859, LG151860, LG151861, LG151862, LG151863, LG151866, LG151868, LG151869, LG151870, LG151872, LG151873, LG151874, LG151875, LG151876, LG151877, LG151878, LG151880, LG151881, LG151882, LG151883, LG151884, LG151885, LG151890, LG151891, LG151892, LG151893, LG151894, LG151895, LG151896, LG151898, LG151899, LG151900, LG151901, LG151903, LG151904, LG151906, LG151907, LG151908, LG151909, LG151917, LG151918, LG151919, LG151920, LG151921, LG151922, LG151923, LG151924, LG151925, LG151926, LG151927, LG151928, LG151930, LG151931, LG151932, LG151933, LG151934, LG151935, LG151936, LG151937, LG151938, LG151939, LG151940, LG151941, LG151942, LG151943, LG151944, LG151945, LG151946, LG151947, LG151948, LG151949, LG151952, LG151953, LG151954, LG151955, LG151957, LG151959, LG151961, LG151963, LG151964, LG151965, LG151967, LG151969, LG151972, LG151977, LG151978, LG151979, LG151981, LG151984, LG151985, LG151986, LG151987, LG151988, LG151989, LG151990, LG151993, LG151994, LG151996, LG151997, LG151998, LG152000, LG152001, LG152002, LG152003, LG152004, LG152005, LG152006, LG152007, LG152008, LG152009, LG152010, LG152011, LG152012, LG152013, LG152014, LG152015, LG152016, LG152017, LG152018, LG152019, LG152020, LG152021, LG152022, LG152023, LG152024, LG152025, LG152026, LG152027, LG152028, LG152029, LG152030, LG152032, LG152033, LG152034, LG152036, LG152037, LG152038, LG152039, LG152044, LG152045, LG152046, LG152048, LG152049, LG152050, LG152051, LG152052, LG152053, LG152054, LG152058, LG152059, LG152060, LG152061, LG152062, LG152063, LG152065, LG152066, LG152067, LG152069, LG152071, LG152072, LG152073, LG152074, LG152076, LG152079, LG152081, LG152082, LG152085, LG152086, LG152087, LG152088, LG152089, LG152090, LG152092, LG152093, LG152094, LG152095, LG152096, LG152097, LG152098, LG152099, LG152100, LG152101, LG152102, LG152103, LG152104, LG152105, LG152106, LG152107, LG152113, LG152114, LG152115, LG152116, LG152117, LG152118, LG152119, LG152120, LG152121, LG152122, LG152124, LG152126, LG152132, LG152133, LG152134, LG152135, LG152140, LG152141, LG152142, LG152143, LG152144, LG152145, LG152146, LG152147, LG152148, LG152150, LG152152, LG152153, LG152154, LG152155, LG152156, LG152158, LG152159, LG152160, LG152161, LG152162, LG152163, LG152164, LG152170, LG152171, LG152172, LG152173, LG152178, LG152179, MD151705, MD151706, MD151707, MD151708, MD151709, MD151710, MD151711, MD151712, MD151713, MD151717, MD151718, MD151719, MD151727, MD151728, MD151729, MD151730, MD151731, MD151733, MD151744, MD151745, MD151746, MD151748, MD151749, MD151750, MD151752, MD151753, MD151754, MD151756, MD151757, MD151758, MD151760, MD151761, MD151762, MD151766, MD151767, MD151768, MD151769, MD151770, MD151771, MD151772, MD151773, MD151774, MD151775, MD151776, MD151779, MD151780, MD151781, MD151782, MD151783, MD151785, MD151786, MD151787, MD151788, MD151789, MD151792, MD151793, MD151794, MD151795, MD151796, MD151797, MD151798, MD151799, MD151800, MD151801, MD151802, MD151803, MD151804, MD151805, MD151806, MD151807, MD151808, MD151812, MD151817, MD151818, MD151819, MD151822, MD151823, MD151824, MD151825, MD151826, MD151827, MD151828, MD151829, MD151830, MD151831, MD151832, MD151833, MD151834, MD151837, MD151839, MD151840, MD151841, MD151842, MD151843, MD151844, MD151845, MD151846, MD151847, MD151848, MD151850, MD151851, MD151852, MD151853, MD151854, MD151855, MD151856, MD151857, MD151858, MD151860, MD151861, MD151862, MD151863, MD151864, MD151865, MD151866, MD151868, MD151869, MD151870, MD151871, MD151872, MD151875, MD151876, MD151877, MD151878, MD151931, MD151932, XL151543, XL151545, XL151546, XL151547, XL151548, XL151549, XL151551, XL151552, XL151556, XL151557, XL151558, XL151559, XL151560, XL151562, XL151563, XL151564, XL151566, XL151567, XL151568, XL151570, and XL151572. ****SERIAL NUMBERS OF UNITS OUTSIDE THE US******************* LG151886, LG151887, LG151888, LG151905, LG151910, LG151911, LG151912, LG151913, LG151914, LG151915, LG151916, LG151950, LG151951, LG151958, LG151960, LG151962, LG151966, LG151973, LG151974, LG151975, LG151976, LG151980, LG151982, LG151983, LG151992, LG151995, LG151999, LG152031, LG152035, LG152040, LG152041, LG152042, LG152043, LG152047, LG152055, LG152056, LG152057, LG152064, LG152075, LG152077, LG152078, LG152080, LG152091, LG152108, LG152109, LG152110, LG152111, LG152112, LG152123, LG152125, LG152127, LG152128, LG152129, LG152130, LG152131, LG152136, LG152137, LG152138, LG152139, LG152149, LG152151, LG152157, LG152165, LG152167, LG152168, LG152169, LG152174, LG152175, LG152176, LG152177, LG152211, LG152212, LG152213, LG152214, LG152215, LG152227, LG152228, LG152229, LG152231, LG152232, MD151685, MD151686, MD151687, MD151688, MD151689, MD151690, MD151691, MD151692, MD151693, MD151694, MD151695, MD151696, MD151697, MD151698, MD151699, MD151700, MD151701, MD151702, MD151703, MD151704, MD151714, MD151715, MD151716, MD151721, MD151722, MD151723, MD151724, MD151725, MD151732, MD151734, MD151735, MD151736, MD151737, MD151738, MD151740, MD151741, MD151742, MD151755, MD151759, MD151763, MD151764, MD151765, MD151777, MD151778, MD151784, MD151790, MD151791, MD151809, MD151810, MD151811, MD151813, MD151814, MD151815, MD151816, MD151820, MD151821, MD151859, MD151873, MD151874, MD151905, MD151906, MD151907, MD151908, MD151909, MD151910, MD151911, MD151912, MD151914, MD151915, MD151916, MD151917, MD151918, MD151919, MD151920, MD151929, MD151930, XL151544, XL151550, XL151561, and XL151571.