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FDA (Device enforcement)Recalled 2023-09-28class i

Covidien: Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

Hazard

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.

Details from the source

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

UPC codes

10884521776494, 20884521823393

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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