Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 4214848 4220271 4222902 4241695 4255331 4290031 4292828 4296992 4304618 4308455 4337270 4337271 4343025 4345418 4354057 4356222 4368783 4370806 4392320 4403653 4406591 4412427 4414383 4424550 4427318 4433469 4433470 4433471 4461704 4465594 6001189 6001190 6003050 6003051 6010585 6018574 6018575 6018576 6027727 6031566 6031568 6051973 6051974 6055166 6055174 100/111/030 15019315018855 3891574 3895035 3901349 3904790 3908090 3930098 3933578 3946325 3949086 3955988 3969651 3973463 3981461 3990362 4000829 4014666 4018136 4026786 4026787 4036208 4047356 4053382 4062712 4065678 4085821 4091975 4103890 4112853 4118068 4127351 4138428 4138429 4141277 4147624 4161530 4169644 4187132 4200189 4206541 4214850 4225676 4228827 4260297 4262331 4269339 4290034 4292829 4304619 4304620 4304621 4337274 4337275 4337276 4340964 4340965 4343026 4343027 4347854 4351770 4358015 4364616 4370809 4377383 4379014 4392322 4403654 4406592 4414889 4417662 4425920 4433472 4433473 4433474 4446988 4452150 4452151 4454684 4456323 4461702 4465588 4465589 4465590 6001208 6010602 6010603 6013487 6018594 6027712 6027714 6031560 6031562 6054526 6055175 100/111/035 15019315018862¿ 3874375 3891590 3897982 3911479 3918158 3921049 3936640 3939719 3946342 3955906 3969652 3973454 3981462 3990363 4000831 4007489 4014667 4036210 4038587 4047358 4053384 4059427 4065675 4075489 4080556 4091976 4100450 4110003 4112854 4124778 4141294 4144599 4159072 4164152 4166606 4169636 4187134 4192162 4206542 4214852 4217903 4220276 4247562 4250638 4260298 4271738 4274653 4295329 4302268 4304623 4306894 4340968 4343030 4343031 4347856 4351771 4361588 4370811 4373209 4377386 4379005 4392324 4394899 4414384 4417660 4424548 4424549 4425919 4427310 4427321 4433475 4433476 4446989 4452143 4452144 4456324 4461701 4465586 6001197 6001198 6001199 6010605 6010606 6010607 6010608 6013488 6018584 6018585 6018586 6027710 6036528 6051970 6054527 6055167 6055176 100/126/025 15019315056758 3874389 3891578 3918145 3939723 3966169 3986493 4047359 4062719 4124776 4147630 4192138 4217908 4290040 4343051 4347863 4373213 4385674 4445290 4452134 6010609 6031564 100/126/030 15019315056765 3891631 3918169 3949087 3955961 4036209 4047361 4059422 4107078 4135632 4169648 4198116 4222910 4247568 4269345 4287239 4343053 4347864 4358021 4380606 4433492 4456321 4461697 6018600 100/126/035 15019315056772 3867283 3884332 3911489 3933571 3954950 4000836 4042230 4065676 4091971 4124773 4150620 4175618 4204344 4277416 4326705 4345430 4364622 4427325 4456327 6018590 100/127/025 15019315019807 3895053 3911512 3942625 3986494 4135609 4150621 4198085 4241703 4262334 4326704 4351776 4380607 4416396 4445291 4446994 6031543 6055170 100/127/030 15019315019814 3897978 3927028 3955989 3969659 4225686 4308456 4412423 4465579 6051961 100/127/035 15019315019821 3874374 3921055 3946346 3997428 4228833 4347866 4356229 4380608 6010610 100/141/025 15019315019029 3867278 3877721 3897949 3904766 3923790 3933584 3936661 3939725 3966170 3981483 4018140 4032458 4038590 4088780 4097361 4110011 4115482 4118074 4121693 4159074 4166631 4169669 4187130 4192164 4214857 4217909 4230673 4241704 4255341 4290041 4290042 4337277 4377393 4380610 4394925 4430791 4454685 4465596 6003052 6010587 6018579 6027729 6031570 6051980 100/141/030 15019315019036 3872612 3877722 3880755 3891596 3891597 3904729 3904730 3908126 3927046 3931212 3936629 3954964 3962947 3969660 3977857 3981479 4062720 4065679 4100443 4107074 4110007 4115490 4118077 4118078 4121704 4121706 4135616 4138439 4141285 4144626 4147632 4153129 4164141 4166602 4175579 4187158 4195299 4217911 4222912 4233557 4243803 4250644 4260304 4271747 4287242 4287243 4380611 4392329 4394926 4406609 4433497 4445295 4445296 4445297 4445299 4448467 4456314 4456328 6027719 6027720 6031565 100/141/035 15019315019043 3874416 3874417 3891587 3897969 3908113 3923774 3931218 3933576 3939726 3969662 3981482 4042224 4047360 4050233 4053381 4062721 4075491 4097371 4109996 4115492 4118082 4118083 4121701 4138434 4141279 4144611 4144612 4150624 4164146 4166604 4192135 4195273 4214860 4220289 4220291 4225683 4247572 4250647 4255346 4260305 4269347 4274658 4282270 4287244 4370817 4377394 4379007 4380612 4392331 4394927 4430792 4454686 4456315 6001193 6003053 6018577 6027730 6031544 6060009
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Product Codes/Lot Numbers:
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 4214848 4220271 4222902 4241695 4255331 4290031 4292828 4296992 4304618 4308455 4337270 4337271 4343025 4345418 4354057 4356222 4368783 4370806 4392320 4403653 4406591 4412427 4414383 4424550 4427318 4433469 4433470 4433471 4461704 4465594 6001189 6001190 6003050 6003051 6010585 6018574 6018575 6018576 6027727 6031566 6031568 6051973 6051974 6055166 6055174 100/111/030 15019315018855 3891574 3895035 3901349 3904790 3908090 3930098 3933578 3946325 3949086 3955988 3969651 3973463 3981461 3990362 4000829 4014666 4018136 4026786 4026787 4036208 4047356 4053382 4062712 4065678 4085821 4091975 4103890 4112853 4118068 4127351 4138428 4138429 4141277 4147624 4161530 4169644 4187132 4200189 4206541 4214850 4225676 4228827 4260297 4262331 4269339 4290034 4292829 4304619 4304620 4304621 4337274 4337275 4337276 4340964 4340965 4343026 4343027 4347854 4351770 4358015 4364616 4370809 4377383 4379014 4392322 4403654 4406592 4414889 4417662 4425920 4433472 4433473 4433474 4446988 4452150 4452151 4454684 4456323 4461702 4465588 4465589 4465590 6001208 6010602 6010603 6013487 6018594 6027712 6027714 6031560 6031562 6054526 6055175 100/111/035 15019315018862¿ 3874375 3891590 3897982 3911479 3918158 3921049 3936640 3939719 3946342 3955906 3969652 3973454 3981462 3990363 4000831 4007489 4014667 4036210 4038587 4047358 4053384 4059427 4065675 4075489 4080556 4091976 4100450 4110003 4112854 4124778 4141294 4144599 4159072 4164152 4166606 4169636 4187134 4192162 4206542 4214852 4217903 4220276 4247562 4250638 4260298 4271738 4274653 4295329 4302268 4304623 4306894 4340968 4343030 4343031 4347856 4351771 4361588 4370811 4373209 4377386 4379005 4392324 4394899 4414384 4417660 4424548 4424549 4425919 4427310 4427321 4433475 4433476 4446989 4452143 4452144 4456324 4461701 4465586 6001197 6001198 6001199 6010605 6010606 6010607 6010608 6013488 6018584 6018585 6018586 6027710 6036528 6051970 6054527 6055167 6055176 100/126/025 15019315056758 3874389 3891578 3918145 3939723 3966169 3986493 4047359 4062719 4124776 4147630 4192138 4217908 4290040 4343051 4347863 4373213 4385674 4445290 4452134 6010609 6031564 100/126/030 15019315056765 3891631 3918169 3949087 3955961 4036209 4047361 4059422 4107078 4135632 4169648 4198116 4222910 4247568 4269345 4287239 4343053 4347864 4358021 4380606 4433492 4456321 4461697 6018600 100/126/035 15019315056772 3867283 3884332 3911489 3933571 3954950 4000836 4042230 4065676 4091971 4124773 4150620 4175618 4204344 4277416 4326705 4345430 4364622 4427325 4456327 6018590 100/127/025 15019315019807 3895053 3911512 3942625 3986494 4135609 4150621 4198085 4241703 4262334 4326704 4351776 4380607 4416396 4445291 4446994 6031543 6055170 100/127/030 15019315019814 3897978 3927028 3955989 3969659 4225686 4308456 4412423 4465579 6051961 100/127/035 15019315019821 3874374 3921055 3946346 3997428 4228833 4347866 4356229 4380608 6010610 100/141/025 15019315019029 3867278 3877721 3897949 3904766 3923790 3933584 3936661 3939725 3966170 3981483 4018140 4032458 4038590 4088780 4097361 4110011 4115482 4118074 4121693 4159074 4166631 4169669 4187130 4192164 4214857 4217909 4230673 4241704 4255341 4290041 4290042 4337277 4377393 4380610 4394925 4430791 4454685 4465596 6003052 6010587 6018579 6027729 6031570 6051980 100/141/030 15019315019036 3872612 3877722 3880755 3891596 3891597 3904729 3904730 3908126 3927046 3931212 3936629 3954964 3962947 3969660 3977857 3981479 4062720 4065679 4100443 4107074 4110007 4115490 4118077 4118078 4121704 4121706 4135616 4138439 4141285 4144626 4147632 4153129 4164141 4166602 4175579 4187158 4195299 4217911 4222912 4233557 4243803 4250644 4260304 4271747 4287242 4287243 4380611 4392329 4394926 4406609 4433497 4445295 4445296 4445297 4445299 4448467 4456314 4456328 6027719 6027720 6031565 100/141/035 15019315019043 3874416 3874417 3891587 3897969 3908113 3923774 3931218 3933576 3939726 3969662 3981482 4042224 4047360 4050233 4053381 4062721 4075491 4097371 4109996 4115492 4118082 4118083 4121701 4138434 4141279 4144611 4144612 4150624 4164146 4166604 4192135 4195273 4214860 4220289 4220291 4225683 4247572 4250647 4255346 4260305 4269347 4274658 4282270 4287244 4370817 4377394 4379007 4380612 4392331 4394927 4430792 4454686 4456315 6001193 6003053 6018577 6027730 6031544 6060009
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1289-2025
Related Recalls
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.