Smiths Medical ASD, Inc.: Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/1

Hazard

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Details from the source

Reason for recall: Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse. Distribution: Worldwide - US Nationwide distribution. Lot/code info: 100/105/025 UDI-DI 15019315018633, Lots 3877711 3911500 3927026 3954958 3969644 3986480 4014665 4050235 4062708 4080550 4110012 4135634 4147621 4159071 4166635 4190224 4209071 4222894 4247556 4255323 4284465 4296990 4308451 4337267 4345413; 100/105/030 UDI-DI 15019315018640, Lots 3880748 3891668 3904782 3931190 3942650 3969646 3990354 4004638 4011059 4050237 4059417 4062709 4077446 4091972 4121698 4144606 4153143 4166633 4192137 4214842 4247557 4255324 4264607 4282245 4304610 4337268 4343014 4345414 4354054 6001192 6010589 6018580 6025898 6054524 6055172; 100/105/030 15019315018640 3955939 100/105/035 15019315018657 3874397 3901353 3904795 3931215 3954951 3973457 3986481 4007482 4023465 4059423 4121695 4150613 4190222 4222896 4269334 4308452 4340958 4347847 4370803 6010588 6059989 100/105/035** 15019315018657 3955939 100/111/020 15019315018831 3884360 3927050 3936628 3969650 3973460 3990360 4018131 4029076 4036214 4047362 4053374 4059424 4068624 4080552 4085815 4110000 4112845 4135636 4144618 4166622 4187114 4195285 4206539 4217899 4241691 4255329 4260296 4271735 4279639 4282246 4282247 4304616 4308454 4337269 4347850 4358010 4361583 4377379 4412425 4414897 4417663 4427307 4433466 4433467 4461705 6003054 6018589 100/111/025 15019315018848 3874369 3880750 3895055 3918122 3930096 3936648 3949085 3955901 3962938 3986487 3990368 4007485 4007486 4018135 4026789 4042235 4047364 4053371 4059426 4065680 4080553 4110009 4110010 4135622 4141293 4147623 4153140 4166621 4187126 4195302 4

UPC codes

15019315018633, 15019315018640, 15019315018657, 15019315018831, 15019315018848, 15019315018855, 15019315018862, 15019315056758, 15019315056765, 15019315056772, 15019315019807, 15019315019814, 15019315019821, 15019315019029, 15019315019036, 15019315019043

Source

Official record: FDA (Device enforcement) ↗

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