Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
Reason for recall: Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation. Distribution: Unknown Quantity: 5709 Lot/code info: Stolen defective products are not appropriately packaged and labeled - Some are missing serial numbers. UDI-DI: 10884521776494, 20884521823393. Known Affected Serial Numbers: 000063, 000076, 000085, 000092, 000093, 000112, 000120, 000121, 000146, 000153, 000154, 000155, 000166, 000179, 000190, 000197, 000202, 000224, 000233, 000238, 000255, 000308, 000329, 000375, 000389, 000436, 000446, 000455, 000464, 000465, 000497, 000512, 000526, 000528, 000546, 000553, 000597, 000607, 000628, 000641, 000648, 000650, 000673, 000677, 000745, 000752, 000753, 000760, 000764, 000769, 000781, 000809, 000810, 000821, 000823, 000847, 000850, 000871, 000879, 000887, 000891, 000913, 000914, 000918, 000939, 000958, 000960, 001015, 001027, 001135, 001140, 001191, 001211, 001348, 001355, 001385, 001418, 001446, 001491, 001504, 001534, 001555, 001561, 001596, 001605, 001621, 001629, 001631, 001669, 001760, 001826, 001829, 001859, 001952, 001985, 002008, 002016, 002017, 002037, 002042, 002056, 002151, 002160, 002174, 002197, 002234, 002242, 002279, 002282, 002291, 002294, 002321, 002322, 002363, 002386, 002480, 002676, 002777, 002780, 002786, 002793, 002853, 002858, 002888, 002908, 002991, 003001, 003090, 003179, 003191, 003201, 003288, 003464, 003678, 003693, 003720, 003733, 003889, 003957, 004035, 004075, 004076, 004178, 004409, 004444, 004491, 004525, 004532, 004545, 004580, 004608, 004610, 004624, 004650, 004664, 004686, 004706, 004722, 004731, 004745, 004749, 004756, 004762, 004765, 004776, 00480
10884521776494, 20884521823393
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.