Z-0420-2016 Class II Terminated
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.