Class 1 Device Recall smiths medical portex BLUselect, tracheostomy tube

• Date Initiated by Firm: June 07, 2024
• Date Posted: September 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3086-2024
• Recall Event ID: 95016
• 510(K)Number: K173384 K173912
• Product Classification: Tube, tracheostomy (w/wo connector) - Product Code BTO
• Product: smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ; 5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ; 6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ; 7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ; 8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ; 9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ; 10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ; 11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ; 12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ; 13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ; 14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ; 15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ; 16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ; 17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075; 18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ; 19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080; 20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ; 21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ; 22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ; 23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ; 24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ; 25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ; 26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ; 27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ; 28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ; 29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ; 30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ; 31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060; 32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070; 33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075; 34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080; 35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085; 36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090; 37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100; 38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060; 39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070; 40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080; 41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090; 42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100; 43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ; 44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ; 45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ; 46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ; 47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ; 48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ; 49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ; 50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ; 51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ; 52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ; 53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0
• Code Information: 101/800/060CZ, Lot Number 3895097; 101/800/060CZ, Lot Number 3925835; 101/800/060CZ, Lot Number 4025600; 101/800/060CZ, Lot Number 4106716; 101/800/060CZ, Lot Number 4230149; 101/800/060CZ, Lot Number 4252500; 101/800/060CZ, Lot Number 4382002; 101/800/070CZ, Lot Number 3895101; 101/800/070CZ, Lot Number 3925960; 101/800/070CZ, Lot Number 3933088; 101/800/070CZ, Lot Number 4010050; 101/800/070CZ, Lot Number 4022790; 101/800/070CZ, Lot Number 4034826; 101/800/070CZ, Lot Number 4037975; 101/800/070CZ, Lot Number 4133612; 101/800/070CZ, Lot Number 4152440; 101/800/070CZ, Lot Number 4156971; 101/800/070CZ, Lot Number 4217804; 101/800/070CZ, Lot Number 4238237; 101/800/070CZ, Lot Number 4249341; 101/800/070CZ, Lot Number 4305944; 101/800/070CZ, Lot Number 4305947; 101/800/070CZ, Lot Number 4368641; 101/800/075CZ, Lot Number 3895100; 101/800/075CZ, Lot Number 3925748; 101/800/075CZ, Lot Number 3933086; 101/800/075CZ, Lot Number 4025599; 101/800/075CZ, Lot Number 4034825; 101/800/075CZ, Lot Number 4037974; 101/800/075CZ, Lot Number 4073768; 101/800/075CZ, Lot Number 4117927; 101/800/075CZ, Lot Number 4134827; 101/800/075CZ, Lot Number 4152439; 101/800/075CZ, Lot Number 4156970; 101/800/075CZ, Lot Number 4238234; 101/800/075CZ, Lot Number 4249234; 101/800/075CZ, Lot Number 4348898; 101/800/075CZ, Lot Number 4348899; 101/800/075CZ, Lot Number 4365892; 101/800/080CZ, Lot Number 3895103; 101/800/080CZ, Lot Number 3909670; 101/800/080CZ, Lot Number 3933044; 101/800/080CZ, Lot Number 4037971; 101/800/080CZ, Lot Number 4052621; 101/800/080CZ, Lot Number 4138225; 101/800/080CZ, Lot Number 4156969; 101/800/080CZ, Lot Number 4224695; 101/800/080CZ, Lot Number 4230078; 101/800/080CZ, Lot Number 4232686; 101/800/080CZ, Lot Number 4245469; 101/800/080CZ, Lot Number 4247407; 101/800/080CZ, Lot Number 4270931; 101/800/080CZ, Lot Number 4291190; 101/800/080CZ, Lot Number 4305933; 101/800/080CZ, Lot Number 4305934; 101/800/080CZ, Lot Number 4305935; 101/800/080CZ, Lot Number 4305936; 101/800/080CZ, Lot Number 4305938; 101/800/085CZ, Lot Number 3922027; 101/800/085CZ, Lot Number 3951221; 101/800/085CZ, Lot Number 4034824; 101/800/085CZ, Lot Number 4256383; 101/800/085CZ, Lot Number 4348861; 101/800/090CZ, Lot Number 3895099; 101/800/090CZ, Lot Number 3951220; 101/800/090CZ, Lot Number 3968406; 101/800/090CZ, Lot Number 4039797; 101/800/090CZ, Lot Number 4197025; 101/800/090CZ, Lot Number 4217803; 101/800/090CZ, Lot Number 4238236; 101/800/090CZ, Lot Number 4261648; 101/800/090CZ, Lot Number 4273231; 101/800/090CZ, Lot Number 4306047; 101/800/090CZ, Lot Number 4310439; 101/800/090CZ, Lot Number 4376612; 101/800/090CZ, Lot Number 4387369; 101/800/100CZ, Lot Number 3895110; 101/800/100CZ, Lot Number 3951219; 101/800/100CZ, Lot Number 4000129; 101/800/100CZ, Lot Number 4230076; 101/800/100CZ, Lot Number 4306058; 101/800/100CZ, Lot Number 4372161; 101/800/100CZ, Lot Number 4386600; 101/800/100CZ, Lot Number 4390744; 101/800/100CZ, Lot Number 4413606; 101/802/060CZ, Lot Number 3906886; 101/802/060CZ, Lot Number 3925839; 101/802/060CZ, Lot Number 4028452; 101/802/060CZ, Lot Number 4382046; 101/802/070CZ, Lot Number 3895109; 101/802/070CZ, Lot Number 3925740; 101/802/070CZ, Lot Number 3972531; 101/802/075CZ, Lot Number 3895104; 101/802/075CZ, Lot Number 3951183; 101/802/075CZ, Lot Number 3968265; 101/802/075CZ, Lot Number 4388729; 101/802/080CZ, Lot Number 3895105; 101/802/080CZ, Lot Number 3951185; 101/802/080CZ, Lot Number 4268672; 101/802/080CZ, Lot Number 4310441; 101/802/080CZ, Lot Number 4423828; 101/802/080CZ, Lot Number 4436040; 101/802/080CZ, Lot Number 4444762; 101/802/080CZ, Lot Number 4456953; 101/802/085CZ, Lot Number 3922029; 101/802/085CZ, Lot Number 3925759; 101/802/085CZ, Lot Number 4028454; 101/802/090CZ, Lot Number 3895106; 101/802/090CZ, Lot Number 3925752; 101/802/090CZ, Lot Number 3954847; 101/802/100CZ, Lot Number 3910328; 101/802/100CZ, Lot Number 3951214; 101/802/100CZ, Lot Number 3968282; 101/810/060CZ, Lot Number 3887495; 101/810/060CZ, Lot Number 3933190; 101/810/060CZ, Lot Number 3948313; 101/810/060CZ, Lot Number 3958315; 101/810/060CZ, Lot Number 4106722; 101/810/060CZ, Lot Number 4268673; 101/810/070CZ, Lot Number 3887478; 101/810/070CZ, Lot Number 4106813; 101/810/070CZ, Lot Number 4243097; 101/810/070CZ, Lot Number 4254571; 101/810/070CZ, Lot Number 4285856; 101/810/075, Lot Number 4271670; 101/810/075CZ, Lot Number 3887504; 101/810/075CZ, Lot Number 3925795; 101/810/075CZ, Lot Number 4010055; 101/810/075CZ, Lot Number 4073763; 101/810/075CZ, Lot Number 4177908; 101/810/075CZ, Lot Number 4222083; 101/810/075CZ, Lot Number 4249233; 101/810/075CZ, Lot Number 4281153; 101/810/075CZ, Lot Number 4381994; 101/810/075CZ, Lot Number 4412129; 101/810/080, Lot Number 3900816; 101/810/080CZ, Lot Number 3887481; 101/810/080CZ, Lot Number 4173265; 101/810/080CZ, Lot Number 4207825; 101/810/080CZ, Lot Number 4217114; 101/810/080CZ, Lot Number 4230143; 101/810/080CZ, Lot Number 4285773; 101/810/080CZ, Lot Number 4306016; 101/810/080CZ, Lot Number 4312272; 101/810/080CZ, Lot Number 4381980; 101/810/080CZ, Lot Number 4387365; 101/810/080CZ, Lot Number 4403461; 101/810/080CZ, Lot Number 4415817; 101/810/080CZ, Lot Number 4423832; 101/810/085CZ, Lot Number 3922028; 101/810/085CZ, Lot Number 3951211; 101/810/085CZ, Lot Number 3989280; 101/810/085CZ, Lot Number 4067915; 101/810/085CZ, Lot Number 4098973; 101/810/085CZ, Lot Number 4152435; 101/810/085CZ, Lot Number 4178022; 101/810/085CZ, Lot Number 4281079; 101/810/085CZ, Lot Number 4306011; 101/810/090CZ, Lot Number 3887482; 101/810/090CZ, Lot Number 3993623; 101/810/090CZ, Lot Number 4106736; 101/810/090CZ, Lot Number 4173266; 101/810/090CZ, Lot Number 4243117; 101/810/090CZ, Lot Number 4306027; 101/810/090CZ, Lot Number 4327669; 101/810/090CZ, Lot Number 4403367; 101/810/090CZ, Lot Number 4426600; 101/810/090CZ, Lot Number 4458561; 101/810/100CZ, Lot Number 3887505; 101/810/100CZ, Lot Number 3909242; 101/810/100CZ, Lot Number 4058669; 101/810/100CZ, Lot Number 4175497; 101/810/100CZ, Lot Number 4217875; 101/810/100CZ, Lot Number 4249333; 101/810/100CZ, Lot Number 4291208; 101/810/100CZ, Lot Number 4310443; 101/810/100CZ, Lot Number 4312263; 101/810/100CZ, Lot Number 4387368; 101/810/100CZ, Lot Number 4397557; 101/812/060CZ, Lot Number 3887479; 101/812/060CZ, Lot Number 3925779; 101/812/060CZ, Lot Number 3959080; 101/812/060CZ, Lot Number 3976752; 101/812/060CZ, Lot Number 4106752; 101/812/060CZ, Lot Number 4294444; 101/812/070CZ, Lot Number 3887499; 101/812/070CZ, Lot Number 3925781; 101/812/070CZ, Lot Number 3948188; 101/812/070CZ, Lot Number 3968279; 101/812/070CZ, Lot Number 4106754; 101/812/070CZ, Lot Number 4242910; 101/812/075CZ, Lot Number 3887552; 101/812/075CZ, Lot Number 3968280; 101/812/075CZ, Lot Number 4217831; 101/812/075CZ, Lot Number 4268677; 101/812/075CZ, Lot Number 4381979; 101/812/075CZ, Lot Number 4413594; 101/812/080CZ, Lot Number 3887488; 101/812/080CZ, Lot Number 3948295; 101/812/080CZ, Lot Number 3989255; 101/812/080CZ, Lot Number 4073770; 101/812/080CZ, Lot Number 4106756; 101/812/080CZ, Lot Number 4227246; 101/812/080CZ, Lot Number 4234757; 101/812/080CZ, Lot Number 4385065; 101/812/085CZ, Lot Number 3922030; 101/812/085CZ, Lot Number 3925793; 101/812/085CZ, Lot Number 4028504; 101/812/085CZ, Lot Number 4191164; 101/812/085CZ, Lot Number 4222085; 101/812/085CZ, Lot Number 4261649; 101/812/085CZ, Lot Number 4382043; 101/812/090CZ, Lot Number 3887489; 101/812/090CZ, Lot Number 3972311; 101/812/090CZ, Lot Number 4075795; 101/812/090CZ, Lot Number 4106757; 101/812/090CZ, Lot Number 4170983; 101/812/090CZ, Lot Number 4217120; 101/812/090CZ, Lot Number 4243118; 101/812/100CZ, Lot Number 3887507; 101/812/100CZ, Lot Number 3948187; 101/812/100CZ, Lot Number 4064797; 101/812/100CZ, Lot Number 4245460; 101/812/100CZ, Lot Number 4259283; 101/812/100CZ, Lot Number 4381995; 101/812/100CZ, Lot Number 4388732; 101/812/100CZ, Lot Number 4413618; 101/812/100CZ, Lot Number 4423838; 101/812/100CZ, Lot Number 4443290; 101/815/060, Lot Number 3933722; 101/815/060, Lot Number 3940999; 101/815/060, Lot Number 3949223; 101/815/060, Lot Number 4014730; 101/815/060, Lot Number 4021067; 101/815/060, Lot Number 4035539; 101/815/060, Lot Number 4091934; 101/815/060, Lot Number 4118283; 101/815/060, Lot Number 4121883; 101/815/060, Lot Number 4159150; 101/815/060, Lot Number 4164109; 101/815/060, Lot Number 4166710; 101/815/060, Lot Number 4174793; 101/815/060, Lot Number 4177293; 101/815/060, Lot Number 4177295; 101/815/060, Lot Number 4187097; 101/815/060, Lot Number 4269270; 101/815/060, Lot Number 4369411; 101/815/060, Lot Number 4369412; 101/815/060, Lot Number 4380967; 101/815/070, Lot Number 3905154; 101/815/070, Lot Number 3949269; 101/815/070, Lot Number 3965244; 101/815/070, Lot Number 4032511; 101/815/070, Lot Number 4039241; 101/815/070, Lot Number 4091935; 101/815/070, Lot Number 4115649; 101/815/070, Lot Number 4121851; 101/815/070, Lot Number 4131921; 101/815/070, Lot Number 4187074; 101/815/070, Lot Number 4187085; 101/815/070, Lot Number 4196637; 101/815/070, Lot Number 4214909; 101/815/070, Lot Number 4219471; 101/815/070, Lot Number 4220399; 101/815/070, Lot Number 4223153; 101/815/070, Lot Number 4260338; 101/815/070, Lot Number 4277368; 101/815/070, Lot Number 4292624; 101/815/070, Lot Number 4294949; 101/815/070, Lot Number 4306727; 101/815/070, Lot Number 4306851; 101/815/070, Lot Number 4306852; 101/815/070, Lot Number 4332676; 101/815/070, Lot Number 4332678; 101/815/070, Lot Number 4332684; 101/815/070, Lot Number 4336640; 101/815/070, Lot Number 4369413; 101/815/075, Lot Number 3956297; 101/815/075, Lot Number 4071378; 101/815/075, Lot Number 4126686; 101/815/075, Lot Number 4174782; 101/815/075, Lot Number 4294945; 101/815/075, Lot Number 4332682; 101/815/075, Lot Number 4362485; 101/815/075, Lot Number 4414625; 101/815/075, Lot Number 4428012; 101/815/080, Lot Number 3905015; 101/815/080, Lot Number 3940109; 101/815/080, Lot Number 3942887; 101/815/080, Lot Number 3965245; 101/815/080, Lot Number 4021055; 101/815/080, Lot Number 4029161; 101/815/080, Lot Number 4058347; 101/815/080, Lot Number 4100474; 101/815/080, Lot Number 4118284; 101/815/080, Lot Number 4169838; 101/815/080, Lot Number 4187081; 101/815/080, Lot Number 4190342; 101/815/080, Lot Number 4192320; 101/815/080, Lot Number 4202303; 101/815/080, Lot Number 4204265; 101/815/080, Lot Number 4204266; 101/815/080, Lot Number 4206466; 101/815/080, Lot Number 4209172; 101/815/080, Lot Number 4274832; 101/815/080, Lot Number 4294948; 101/815/080, Lot Number 4336646; 101/815/080, Lot Number 4336649; 101/815/080, Lot Number 4336668; 101/815/085, Lot Number 3956296; 101/815/085, Lot Number 4071392; 101/815/085, Lot Number 4090264; 101/815/085, Lot Number 4209173; 101/815/085, Lot Number 4332683; 101/815/085, Lot Number 4369414; 101/815/090, Lot Number 3933809; 101/815/090, Lot Number 3949146; 101/815/090, Lot Number 4011017; 101/815/090, Lot Number 4021088; 101/815/090, Lot Number 4026491; 101/815/090, Lot Number 4076707; 101/815/090, Lot Number 4159151; 101/815/090, Lot Number 4169840; 101/815/090, Lot Number 4169841; 101/815/090, Lot Number 4178241; 101/815/090, Lot Number 4185327; 101/815/090, Lot Number 4200170; 101/815/090, Lot Number 4200171; 101/815/090, Lot Number 4204267; 101/815/090, Lot Number 4212316; 101/815/090, Lot Number 4216557; 101/815/090, Lot Number 4260339; 101/815/090, Lot Number 4279525; 101/815/090, Lot Number 4294947; 101/815/090, Lot Number 4334212; 101/815/090, Lot Number 4336647; 101/815/090, Lot Number 4336650; 101/815/100, Lot Number 3933697; 101/815/100, Lot Number 4021081; 101/815/100, Lot Number 4029154; 101/815/100, Lot Number 4112822; 101/815/100, Lot Number 4148895; 101/815/100, Lot Number 4161638; 101/815/100, Lot Number 4169842; 101/815/100, Lot Number 4187096; 101/815/100, Lot Number 4192321; 101/815/100, Lot Number 4206174; 101/815/100, Lot Number 4284378; 101/817/060, Lot Number 3905152; 101/817/060, Lot Number 4106973; 101/817/060, Lot Number 4174794; 101/817/070, Lot Number 3956189; 101/817/070, Lot Number 3986585; 101/817/070, Lot Number 4107000; 101/817/070, Lot Number 4118288; 101/817/070, Lot Number 4130527; 101/817/070, Lot Number 4187078; 101/817/070, Lot Number 4208001; 101/817/080, Lot Number 3933831; 101/817/080, Lot Number 3962715; 101/817/080, Lot Number 4062550; 101/817/080, Lot Number 4068195; 101/817/080, Lot Number 4230801; 101/817/080, Lot Number 4294937; 101/817/090, Lot Number 3941008; 101/817/090, Lot Number 4071380; 101/817/090, Lot Number 4076692; 101/817/090, Lot Number 4106651; 101/817/100, Lot Number 3933799; 101/817/100, Lot Number 4187080; 101/860/060CZ, Lot Number 3895092; 101/860/060CZ, Lot Number 3951193; 101/860/060CZ, Lot Number 4010035; 101/860/060CZ, Lot Number 4058593; 101/860/060CZ, Lot Number 4117932; 101/860/060CZ, Lot Number 4134876; 101/860/060CZ, Lot Number 4156952; 101/860/060CZ, Lot Number 4177861; 101/860/060CZ, Lot Number 4242923; 101/860/060CZ, Lot Number 4376593; 101/860/070CZ, Lot Number 3887509; 101/860/070CZ, Lot Number 3895108; 101/860/070CZ, Lot Number 3951303; 101/860/070CZ, Lot Number 3959094; 101/860/070CZ, Lot Number 3993578; 101/860/070CZ, Lot Number 4010067; 101/860/070CZ, Lot Number 4017181; 101/860/070CZ, Lot Number 4022712; 101/860/070CZ, Lot Number 4025593; 101/860/070CZ, Lot Number 4037923; 101/860/070CZ, Lot Number 4039786; 101/860/070CZ, Lot Number 4052498; 101/860/070CZ, Lot Number 4053320; 101/860/070CZ, Lot Number 4058579; 101/860/070CZ, Lot Number 4061184; 101/860/070CZ, Lot Number 4062929; 101/860/070CZ, Lot Number 4067465; 101/860/070CZ, Lot Number 4067814; 101/860/070CZ, Lot Number 4074986; 101/860/070CZ, Lot Number 4138104; 101/860/070CZ, Lot Number 4163119; 101/860/070CZ, Lot Number 4165742; 101/860/070CZ, Lot Number 4170834; 101/860/070CZ, Lot Number 4183961; 101/860/070CZ, Lot Number 4186645; 101/860/070CZ, Lot Number 4186963; 101/860/070CZ, Lot Number 4198020; 101/860/070CZ, Lot Number 4202488; 101/860/070CZ, Lot Number 4205530; 101/860/070CZ, Lot Number 4221990; 101/860/070CZ, Lot Number 4232682; 101/860/070CZ, Lot Number 4234708; 101/860/070CZ, Lot Number 4234709; 101/860/070CZ, Lot Number 4249306; 101/860/070CZ, Lot Number 4252463; 101/860/070CZ, Lot Number 4252464; 101/860/070CZ, Lot Number 4285771; 101/860/070CZ, Lot Number 4294329; 101/860/070CZ, Lot Number 4303383; 101/860/070CZ, Lot Number 4306006; 101/860/070CZ, Lot Number 4306007; 101/860/070CZ, Lot Number 4306008; 101/860/070CZ, Lot Number 4368707; 101/860/070CZ, Lot Number 4370061; 101/860/075CZ, Lot Number 3895094; 101/860/075CZ, Lot Number 3909675; 101/860/075CZ, Lot Number 3951196; 101/860/075CZ, Lot Number 3951197; 101/860/075CZ, Lot Number 3954753; 101/860/075CZ, Lot Number 4002904; 101/860/075CZ, Lot Number 4005269; 101/860/075CZ, Lot Number 4010074; 101/860/075CZ, Lot Number 4017180; 101/860/075CZ, Lot Number 4020216; 101/860/075CZ, Lot Number 4022713; 101/860/075CZ, Lot Number 4034797; 101/860/075CZ, Lot Number 4037922; 101/860/075CZ, Lot Number 4052614; 101/860/075CZ, Lot Number 4054784; 101/860/075CZ, Lot Number 4054785; 101/860/075CZ, Lot Number 4054787; 101/860/075CZ, Lot Number 4062434; 101/860/075CZ, Lot Number 4062931; 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• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: customer Service; 800-216-8806
• Manufacturer Reason for Recall: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
• FDA Determined Cause: Process control
• Action: Smiths Medical issued an URGENT MEDICAL DEVCIE NOTIFICATION to its consignees on 06/07/2024 via traceable mailing. The notice explained the issue with the device, potential risk to the patient, and requested the affected devices be discarded. Distributor were directed to forward the notice to their customers. For questions: Customer service: customerservice@icumed.com; 800-258-5361) Complaints: globalcomplaints@icumed.com; 866-216-8806
• Quantity in Commerce: 799732 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BTO; 510(K)s with Product Code = BTO