Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Names:
- BLUselect Tracheostomy Tube Kits
- BLUselect Suctionaid Tracheostomy Tube Kits
- BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Forceps
- BLUperc Dilation Procedural Tray with Single Stage Dilator Products
- BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube
- Lot/Serial Numbers: See full list of affected products
What to Do
- Identify any affected products at the institution based on product codes and lot numbers.
- Do not use affected products.
- Dispose of affected products or quarantine them out of use.
On June 13, 2024, Smiths Medical sent all affected customers an Urgent Medical Device Notification letter recommending the following actions:
- Check all inventory for the specific lots of the affected product codes and discontinue use.
- Discard all affected products following the institution's process for disposal.
- Quarantine products if disposal is not immediately available.
- Share the notification with all potential device users, including at other locations where the devices may be used.
- Complete and return the customer response form to smithsmedical8551@sedgwick.com within 10 days of receipt.
- Contact your local representative for replacement product and/or a credit.
- Distributors should immediately forward the notice to any customers who may have received affected product.
- Request that they complete the response form and return it to smithsmedical8551@sedgwick.com.
Reason for Recall
Smiths Medical is recalling specific lots of the BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which can lead to inadequate ventilation and increased risk of aspiration.
The use of affected product may cause serious adverse health consequences, including aspiration and death.
There have been 12 reported injuries. There have been no reports of death.
Device Use
The BLUselect tracheostomy tube (BLUselect) is a polyvinyl chloride (PVC) tracheostomy tube for adults who need an artificial airway after trauma or due to a medical condition.
The BLUgriggs percutaneous dilation procedural tray with BLUselect trach tubes (BLUgriggs) and BLUperc Percutaneous Diliation Procedural Tray with BLUselect trach tubes (BLUperc) are also used for adults who need an artificial airway after trauma or due to a medical condition, but are available in kits that include additional proprietary procedural components to help health care providers with tracheostomy insertion.
Contact Information
Customers in the U.S. with questions about this recall should contact Smiths Medical customer service at 1-(800)-0258-5361 or Customerservice@icumed.com.
Full List of Affected Devices
| Product Name | Item Number | Lot Number |
|---|---|---|
| BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY) | 101/540/080 | 3943992 4258998 |
| BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY) | 101/540/090 | 4309778 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube | 101/541/070 | 3887542 3913366 4202486 4350937 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube | 101/541/080 | 3887517 3910324 3912758 4170885 4184037 4310310 4312324 4332049 4332050 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube | 101/541/090 | 3887526 3925818 4234865 4266477 4310313 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps | 101/543/070 | 3887541 4310304 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps | 101/543/080 | 3887527 3910325 4310447 4332051 4332052 4332053 4332054 4382017 4382018 4382019 4382020 4382021 4382022 4382023 4382024 4382025 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps | 101/543/090 | 3887518 4384983 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube | 101/891/070 | 3910414 3925816 4117953 4156869 4205521 4232678 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube | 101/891/080 | 3887523 3896997 3896998 4306752 4388711 |
| BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube | 101/891/090 | 3913655 3925770 4005342 4310412 |
| BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) | 101/892/070 | 3950087 |
| BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) | 101/892/080 | 3943993 4165114 4226926 |
| BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) | 101/892/090 | 3944020 4194294 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps | 101/893/070 | 3925807 4005284 4005285 4089723 4117954 4138223 4189353 4270948 4281033 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps | 101/893/080 | 3910326 3912757 4005351 4010052 4070524 4165747 4205522 4238251 4281154 4281202 4285878 4289001 4310416 4310417 4310418 4310419 4343143 4382056 4382057 4382058 4382059 4382060 4382061 |
| BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps | 101/893/090 | 4310435 |
| Product Name | Item Number | Lot Numbers |
|---|---|---|
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube |
101/561/070 | 3887555 3928959 4005346 4217858 4234862 4266405 4348810 |
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube |
101/561/080 | 3887536 3906566 3906567 3906568 4217859 4232677 4238252 4249230 4281149 4281150 4283700 4285877 4288974 4291189 4304152 4308334 4348877 4348878 4348879 4348883 4348884 4348885 4348886 4348892 4348893 4382035 4382036 4382037 4382038 4382039 4382040 4386515 4386516 4386517 4386518 4396543 4396544 4396545 4399795 4399796 4399797 4399798 4399799 4405137 4408626 4412102 4412103 4412104 4415777 4415778 4415785 |
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube |
101/561/090 | 3887528 3928993 3976736 4170968 4205592 4234863 4242949 4281078 4285761 4310484 4310485 4310486 4310487 4310488 4382032 4382034 4397559 4397560 4415811 4439066 4450465 |
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube |
101/563/070 | 3887520 3925814 3948836 3965003 4010058 4017238 4054722 4054723 4054801 4165746 4234758 4245279 4249227 4281148 |
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube |
101/563/080 | 3887521 3910412 3925815 3952030 4009963 4054725 4054726 4061095 4070503 4070504 4073772 4100287 4100288 4103806 4115434 4147040 4149715 4156960 4175503 4199278 4205593 4208994 4217863 4224557 4234759 4281042 4283716 4283717 4283718 4285933 4285934 4285935 4285936 4348839 4348840 4348841 4348845 4348847 4348848 4348849 4348850 4348851 4348857 4348858 4348859 4348860 4350944 4350945 4354160 4385041 4385042 4385043 4385046 4385047 4385048 4385049 4385050 4385051 4385052 4396414 4396415 4396416 4396419 4396420 4396534 4396535 4396536 4396537 |
|
BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube |
101/563/090 | 3913653 3925768 3980266 4009974 4061111 4094349 4106839 4115435 4156962 4170970 4212065 4227249 4238178 4281031 4348865 4348866 4348867 4386559 4408641 4412148 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY) |
101/595/070 | 3898766 4002180 4008828 4032081 4060523 4086681 4168564 4234424 4242669 4256056 4280697 4293992 4324235 4333064 4352941 4415588 4415609 4423960 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY) |
101/595/080 | 3898767 3950077 3950078 3987811 3991671 4008820 4032077 4032079 4060526 4072732 4086680 4098486 4110835 4128476 4131412 4148995 4163147 4179977 4256035 4259012 4265777 4272986 4283836 4296804 4324236 4326879 4330616 4339190 4341351 4425478 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY) |
101/595/090 | 3898768 3944042 3950056 3987809 4008834 4008836 4036473 4036503 4060529 4098459 4110836 4168614 4177105 4183504 4263406 4265778 4291330 4294002 4324771 4330618 4344183 4423957 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/596/070 | 3944058 3967805 4008830 4060560 4098464 4116821 4123503 4134674 4240514 4241327 4263399 4275910 4285358 4415589 4423966 4428303 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/596/080 | 3898770 3979602 3979615 4008832 4036527 4060531 4069871 4101970 4110837 4119536 4131437 4146207 4179935 4241328 4246523 4252236 4256036 4268459 4307794 4415596 4436549 |
|
BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/596/090 |
3944050 |
| Product Names | Item Number | Lot Numbers |
|---|---|---|
| BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX | 101/800/060CZ | 3895097 3925835 4025600 4106716 4230149 4252500 4382002 |
| BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX | 101/800/070CZ | 3895101 3925960 3933088 4010050 4022790 4034826 4037975 4133612 4152440 4156971 4217804 4238237 4249341 4305944 4305947 4368641 |
|
BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX |
101/800/075CZ | 3895100 3925748 3933086 4025599 4034825 4037974 4073768 4117927 4134827 4152439 4156970 4238234 4249234 4348898 4348899 4365892 |
|
BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX |
101/800/080CZ | 3895103 3909670 3933044 4037971 4052621 4138225 4156969 4224695 4230078 4232686 4245469 4247407 4270931 4291190 4305933 4305934 4305935 4305936 4305938 |
|
BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX |
101/800/085CZ | 3922027 3951221 4034824 4256383 4348861 |
| BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX | 101/800/090CZ | 3895099 3951220 3968406 4039797 4197025 4217803 4238236 4261648 4273231 4306047 4310439 4376612 4387369 |
|
BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX |
101/800/100CZ | 3895110 3951219 4000129 4230076 4306058 4372161 4386600 4390744 4413606 |
|
BLUSELECT 6.0, CUFFED, FEN, 10/BX |
101/802/060CZ | 3906886 3925839 4028452 4382046 |
| BLUSELECT 7.0, CUFFED, FEN, 10/BX | 101/802/070CZ | 3895109 3925740 3972531 |
| BLUSELECT 7.5, CUFFED, FEN, 10/BX | 101/802/075CZ | 3895104 3951183 3968265 4388729 |
|
BLUSELECT 8.0, CUFFED, FEN, 10/BX |
101/802/080CZ | 3895105 3951185 4268672 4310441 4423828 4436040 4444762 4456953 |
|
BLUSELECT 8.5, CUFFED, FEN, 10/BX |
101/802/085CZ | 3922029 3925759 4028454 |
|
BLUSELECT 9.0, CUFFED, FEN, 10/BX |
101/802/090CZ | 3895106 3925752 3954847 |
| BLUSELECT 10.0, CUFFED, FEN, 10/BX | 101/802/100CZ | 3910328 3951214 3968282 |
|
BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA |
101/810/060CZ | 3887495 3933190 3948313 3958315 4106722 4268673 |
|
BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA |
101/810/070CZ | 3887478 4106813 4243097 4254571 4285856 |
|
BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA |
4271670 | |
|
BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA |
101/810/075CZ | 3887504 3925795 4010055 4073763 4177908 4222083 4249233 4281153 4381994 4412129 |
|
BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, NON-FEN, 1/EA |
101/810/080 | 3900816 |
|
BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA |
101/810/080CZ | 3887481 4173265 4207825 4217114 4230143 4285773 4306016 4312272 4381980 4387365 4403461 4415817 4423832 |
|
BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, NON-FEN, 1/EA |
101/810/085CZ | 3922028 3951211 3989280 4067915 4098973 4152435 4178022 4281079 4306011 |
| BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, NON-FEN, 1/EA | 101/810/090CZ | 3887482 3993623 4106736 4173266 4243117 4306027 4327669 4403367 4426600 4458561 |
|
BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, NON-FEN, 1/EA |
101/810/100CZ | 3887505 3909242 4058669 4175497 4217875 4249333 4291208 4310443 4312263 4387368 4397557 |
|
BLUSELECT 6.0, CUFFED, FEN, 1/EA |
101/812/060CZ | 3887479 3925779 3959080 3976752 4106752 4294444 |
|
BLUSELECT 7.0, CUFFED, FEN, 1/EA |
101/812/070CZ | 3887499 3925781 3948188 3968279 4106754 4242910 |
|
BLUSELECT 7.5, CUFFED, FEN, 1/EA |
101/812/075CZ | 3887552 3968280 4217831 4268677 4381979 4413594 |
|
BLUSELECT 8.0, CUFFED, FEN, 1/EA |
101/812/080CZ | 3887488 3948295 3989255 4073770 4106756 4227246 4234757 4385065 |
|
BLUSELECT 8.5, CUFFED, FEN, 1/EA |
101/812/085CZ | 3922030 3925793 4028504 4191164 4222085 4261649 4382043 |
|
BLUSELECT 9.0, CUFFED, FEN, 1/EA |
101/812/090CZ | 3887489 3972311 4075795 4106757 4170983 4217120 4243118 |
| BLUSELECT 10.0, CUFFED, FEN, 1/EA | 101/812/100CZ | 3887507 3948187 4064797 4245460 4259283 4381995 4388732 4413618 4423838 4443290 |
|
BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/060 | 3933722 3940999 3949223 4014730 4021067 4035539 4091934 4118283 4121883 4159150 4164109 4166710 4174793 4177293 4177295 4187097 4269270 4369411 4369412 4380967 |
|
BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/070 | 3905154 3949269 3965244 4032511 4039241 4091935 4115649 4121851 4131921 4187074 4187085 4196637 4214909 4219471 4220399 4223153 4260338 4277368 4292624 4294949 4306727 4306851 4306852 4332676 4332678 4332684 4336640 4369413 |
|
BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/075 | 3956297 4071378 4126686 4174782 4294945 4332682 4362485 4414625 4428012 |
|
BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/080 | 3905015 3940109 3942887 3965245 4021055 4029161 4058347 4100474 4118284 4169838 4187081 4190342 4192320 4202303 4204265 4204266 4206466 4209172 4274832 4294948 4336646 4336649 4336668 |
|
BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/085 | 3956296 4071392 4090264 4209173 4332683 4369414 |
|
BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA |
101/815/090 | 3933809 3949146 4011017 4021088 4026491 4076707 4159151 4169840 4169841 4178241 4185327 4200170 4200171 4204267 4212316 4216557 4260339 4279525 4294947 4334212 4336647 4336650 |
| BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA | 101/815/100 | 3933697 4021081 4029154 4112822 4148895 4161638 4169842 4187096 4192321 4206174 4284378 |
|
BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA |
101/817/060 | 3905152 4106973 4174794 |
|
BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA |
101/817/070 | 3956189 3986585 4107000 4118288 4130527 4187078 4208001 |
|
BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA |
101/817/080 | 3933831 3962715 4062550 4068195 4230801 4294937 |
|
BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA |
101/817/090 | 3941008 4071380 4076692 4106651 |
|
BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA |
101/817/100 | 3933799 4187080 |
|
BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX |
101/860/060CZ | 3895092 3951193 4010035 4058593 4117932 4134876 4156952 4177861 4242923 4376593 |
|
BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX |
101/860/070CZ | 3887509 3895108 3951303 3959094 3993578 4010067 4017181 4022712 4025593 4037923 4039786 4052498 4053320 4058579 4061184 4062929 4067465 4067814 4074986 4138104 4163119 4165742 4170834 4183961 4186645 4186963 4198020 4202488 4205530 4221990 4232682 4234708 4234709 4249306 4252463 4252464 4285771 4294329 4303383 4306006 4306007 4306008 4368707 4370061 |
|
BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX |
101/860/075CZ | 3895094 3909675 3951196 3951197 3954753 4002904 4005269 4010074 4017180 4020216 4022713 4034797 4037922 4052614 4054784 4054785 4054787 4062434 4062931 4065368 4065369 4067466 4117933 4122876 4127325 4129462 4133614 4134878 4138103 4139223 4139224 4165615 4170859 4183962 4183963 4186583 4186965 4189388 4197067 4199269 4199270 4212066 4214633 4214634 4217813 4221051 4224578 4225227 4242918 4243105 4245286 4249223 4252465 4254572 4259236 4270939 4281157 4285842 4285843 4285844 4294330 4306004 4306005 4312287 4312288 4317594 4336058 4368643 4382006 4382007 4386514 4387362 4408613 |
|
BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX |
101/860/080CZ | 3887546 3895095 3903503 3909276 3951327 3968390 3977665 3980383 3993592 4002998 4009812 4009826 4017177 4017243 4017244 4017245 4026070 4031414 4031415 4031416 4034842 4037140 4037141 4037986 4041420 4054804 4054805 4057098 4058607 4058608 4061058 4061061 4061062 4067791 4071181 4071182 4079446 4079447 4079448 4133622 4134843 4134844 4134845 4134846 4136573 4136574 4136575 4165613 4165614 4170920 4178020 4179046 4183972 4186574 4186575 4189343 4191167 4191168 4195032 4202463 4205543 4207746 4211996 4211997 4211998 4214635 4217853 4219600 4221985 4231321 4231322 4232674 4234707 4242937 4249310 4252471 4252472 4254577 4254578 4259268 4259269 4281080 4281081 4283735 4285774 4285775 4305958 4305959 4312278 4312279 4312280 4319745 4319746 4357891 4365949 4376685 4376686 4376687 4384987 4384988 4386575 4388728 4392808 4392809 4405273 4405274 |
|
BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX |
101/860/085CZ | 3895107 3951199 3964928 4010054 4020273 4031338 4054788 4079454 4129463 4138224 4165743 4177836 4197019 4205591 4214079 4238235 4249237 4256364 4270940 4310532 4368644 4382005 |
|
BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX |
101/860/090CZ | 3895091 3914422 3951202 3954853 3989279 4009810 4017242 4030604 4037924 4058605 4071183 4100371 4103825 4117879 4124564 4134881 4138175 4183964 4183965 4191506 4199354 4209002 4232675 4239848 4249235 4252466 4276630 4285839 4306063 4306064 4310533 4382009 4385029 |
|
BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX |
101/860/100CZ | 3895093 3925786 3951305 3968281 4010004 4025595 4054789 4199355 4217881 4285765 4412135 |
|
BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA |
101/870/060CZ | 3887510 3925734 3951306 4031337 4106745 4217882 |
|
BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA |
101/870/070CZ | 3889311 3951204 3968404 4017237 4022711 4034792 4058662 4073762 4134828 4138214 4156953 4165744 4178001 4217826 4249291 4256336 4283719 4291171 |
| BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA | 101/870/075CZ | 3906881 3951207 3968405 4054813 4058606 4061022 4134829 4138176 4183954 4212004 4238185 4249236 4270941 4276631 4382010 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA | 101/870/080CZ | 3887515 3951288 3980351 3989180 4017250 4051928 4054796 4070522 4117931 4134866 4138056 4156930 4163106 4208997 4238168 4254564 4303380 4310523 4312285 4317581 4319800 4368642 4388736 4390747 |
| 101/870/085CZ | 3887484 3925788 4002986 4054842 4085217 4110784 4121517 4156983 4183981 4212070 4245285 4249238 4376585 |
|
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/870/090CZ | 3892136 3907683 3951191 3962340 4000188 4061185 4075797 4106832 4129451 4138105 4155508 4178002 4183974 4242948 4249307 4249334 4276656 4285763 4285764 4303381 4387367 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/870/100CZ | 3887465 3925771 3996000 4075798 4087868 4106718 4209008 4217806 4245461 4256343 4306010 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/060 | 3973580 3994206 4077390 4077409 4097405 4106652 4121852 4174792 4185328 4228918 4294942 4306861 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/070 | 3965241 3997476 4040743 4040744 4040748 4083147 4090267 4106653 4106657 4130528 4219470 4244044 4244045 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/075 | 3956207 3965238 4106984 4230803 4294936 4318743 4380983 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/080 | 3905060 4038638 4071393 4083162 4088887 4091522 4106655 4124771 4187079 4187084 4202304 4220404 4279527 4294941 4375952 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/085 | 3956339 4106981 4119879 4187077 4202297 4216554 |
| BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN | 101/875/090 | 4034431 4067217 4068186 4106650 4106999 4115631 4118290 4187086 4206467 4216550 4220407 |
|
BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN |
101/875/100 | 3905062 |
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.