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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95016

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 07, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-3086-2024
Recall number
Z-3086-2024
Initiated
June 07, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
799732 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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; 101/860/075CZ, Lot Number 4065368; 101/860/075CZ, Lot Number 4065369; 101/860/075CZ, Lot Number 4067466; 101/860/075CZ, Lot Number 4117933; 101/860/075CZ, Lot Number 4122876; 101/860/075CZ, Lot Number 4127325; 101/860/075CZ, Lot Number 4129462; 101/860/075CZ, Lot Number 4133614; 101/860/075CZ, Lot Number 4134878; 101/860/075CZ, Lot Number 4138103; 101/860/075CZ, Lot Number 4139223; 101/860/075CZ, Lot Number 4139224; 101/860/075CZ, Lot Number 4165615; 101/860/075CZ, Lot Number 4170859; 101/860/075CZ, Lot Number 4183962; 101/860/075CZ, Lot Number 4183963; 101/860/075CZ, Lot Number 4186583; 101/860/075CZ, Lot Number 4186965; 101/860/075CZ, Lot Number 4189388; 101/860/075CZ, Lot Number 4197067; 101/860/075CZ, Lot Number 4199269; 101/860/075CZ, Lot Number 4199270; 101/860/075CZ, Lot Number 4212066; 101/860/075CZ, Lot Number 4214633; 101/860/075CZ, Lot Number 4214634; 101/860/075CZ, Lot Number 4217813; 101/860/075CZ, Lot Number 4221051; 101/860/075CZ, Lot Number 4224578; 101/860/075CZ, Lot Number 4225227; 101/860/075CZ, Lot Number 4242918; 101/860/075CZ, Lot Number 4243105; 101/860/075CZ, Lot Number 4245286; 101/860/075CZ, Lot Number 4249223; 101/860/075CZ, Lot Number 4252465; 101/860/075CZ, Lot Number 4254572; 101/860/075CZ, Lot Number 4259236; 101/860/075CZ, Lot Number 4270939; 101/860/075CZ, Lot Number 4281157; 101/860/075CZ, Lot Number 4285842; 101/860/075CZ, Lot Number 4285843; 101/860/075CZ, Lot Number 4285844; 101/860/075CZ, Lot Number 4294330; 101/860/075CZ, Lot Number 4306004; 101/860/075CZ, Lot Number 4306005; 101/860/075CZ, Lot Number 4312287; 101/860/075CZ, Lot Number 4312288; 101/860/075CZ, Lot Number 4317594; 101/860/075CZ, Lot Number 4336058; 101/860/075CZ, Lot Number 4368643; 101/860/075CZ, Lot Number 4382006; 101/860/075CZ, Lot Number 4382007; 101/860/075CZ, Lot Number 4386514; 101/860/075CZ, Lot Number 4387362; 101/860/075CZ, Lot Number 4408613; 101/860/080CZ, Lot Number 3887546; 101/860/080CZ, Lot Number 3895095; 101/860/080CZ, Lot Number 3903503; 101/860/080CZ, Lot Number 3909276; 101/860/080CZ, Lot Number 3951327; 101/860/080CZ, Lot Number 3968390; 101/860/080CZ, Lot Number 3977665; 101/860/080CZ, Lot Number 3980383; 101/860/080CZ, Lot Number 3993592; 101/860/080CZ, Lot Number 4002998; 101/860/080CZ, Lot Number 4009812; 101/860/080CZ, Lot Number 4009826; 101/860/080CZ, Lot Number 4017177; 101/860/080CZ, Lot Number 4017243; 101/860/080CZ, Lot Number 4017244; 101/860/080CZ, Lot Number 4017245; 101/860/080CZ, Lot Number 4026070; 101/860/080CZ, Lot Number 4031414; 101/860/080CZ, Lot Number 4031415; 101/860/080CZ, Lot Number 4031416; 101/860/080CZ, Lot Number 4034842; 101/860/080CZ, Lot Number 4037140; 101/860/080CZ, Lot Number 4037141; 101/860/080CZ, Lot Number 4037986; 101/860/080CZ, Lot Number 4041420; 101/860/080CZ, Lot Number 4054804; 101/860/080CZ, Lot Number 4054805; 101/860/080CZ, Lot Number 4057098; 101/860/080CZ, Lot Number 4058607; 101/860/080CZ, Lot Number 4058608; 101/860/080CZ, Lot Number 4061058; 101/860/080CZ, Lot Number 4061061; 101/860/080CZ, Lot Number 4061062; 101/860/080CZ, Lot Number 4067791; 101/860/080CZ, Lot Number 4071181; 101/860/080CZ, Lot Number 4071182; 101/860/080CZ, Lot Number 4079446; 101/860/080CZ, Lot Number 4079447; 101/860/080CZ, Lot Number 4079448; 101/860/080CZ, Lot Number 4133622; 101/860/080CZ, Lot Number 4134843; 101/860/080CZ, Lot Number 4134844; 101/860/080CZ, Lot Number 4134845; 101/860/080CZ, Lot Number 4134846; 101/860/080CZ, Lot Number 4136573; 101/860/080CZ, Lot Number 4136574; 101/860/080CZ, Lot Number 4136575; 101/860/080CZ, Lot Number 4165613; 101/860/080CZ, Lot Number 4165614; 101/860/080CZ, Lot Number 4170920; 101/860/080CZ, Lot Number 4178020; 101/860/080CZ, Lot Number 4179046; 101/860/080CZ, Lot Number 4183972; 101/860/080CZ, Lot Number 4186574; 101/860/080CZ, Lot Number 4186575; 101/860/080CZ, Lot Number 4189343; 101/860/080CZ, Lot Number 4191167; 101/860/080CZ, Lot Number 4191168; 101/860/080CZ, Lot Number 4195032; 101/860/080CZ, Lot Number 4202463; 101/860/080CZ, Lot Number 4205543; 101/860/080CZ, Lot Number 4207746; 101/860/080CZ, Lot Number 4211996; 101/860/080CZ, Lot Number 4211997; 101/860/080CZ, Lot Number 4211998; 101/860/080CZ, Lot Number 4214635; 101/860/080CZ, Lot Number 4217853; 101/860/080CZ, Lot Number 4219600; 101/860/080CZ, Lot Number 4221985; 101/860/080CZ, Lot Number 4231321; 101/860/080CZ, Lot Number 4231322; 101/860/080CZ, Lot Number 4232674; 101/860/080CZ, Lot Number 4234707; 101/860/080CZ, Lot Number 4242937; 101/860/080CZ, Lot Number 4249310; 101/860/080CZ, Lot Number 4252471; 101/860/080CZ, Lot Number 4252472; 101/860/080CZ, Lot Number 4254577; 101/860/080CZ, Lot Number 4254578; 101/860/080CZ, Lot Number 4259268; 101/860/080CZ, Lot Number 4259269; 101/860/080CZ, Lot Number 4281080; 101/860/080CZ, Lot Number 4281081; 101/860/080CZ, Lot Number 4283735; 101/860/080CZ, Lot Number 4285774; 101/860/080CZ, Lot Number 4285775; 101/860/080CZ, Lot Number 4305958; 101/860/080CZ, Lot Number 4305959; 101/860/080CZ, Lot Number 4312278; 101/860/080CZ, Lot Number 4312279; 101/860/080CZ, Lot Number 4312280; 101/860/080CZ, Lot Number 4319745; 101/860/080CZ, Lot Number 4319746; 101/860/080CZ, Lot Number 4357891; 101/860/080CZ, Lot Number 4365949; 101/860/080CZ, Lot Number 4376685; 101/860/080CZ, Lot Number 4376686; 101/860/080CZ, Lot Number 4376687; 101/860/080CZ, Lot Number 4384987; 101/860/080CZ, Lot Number 4384988; 101/860/080CZ, Lot Number 4386575; 101/860/080CZ, Lot Number 4388728; 101/860/080CZ, Lot Number 4392808; 101/860/080CZ, Lot Number 4392809; 101/860/080CZ, Lot Number 4405273; 101/860/080CZ, Lot Number 4405274; 101/860/085CZ, Lot Number 3895107; 101/860/085CZ, Lot Number 3951199; 101/860/085CZ, Lot Number 3964928; 101/860/085CZ, Lot Number 4010054; 101/860/085CZ, Lot Number 4020273; 101/860/085CZ, Lot Number 4031338; 101/860/085CZ, Lot Number 4054788; 101/860/085CZ, Lot Number 4079454; 101/860/085CZ, Lot Number 4129463; 101/860/085CZ, Lot Number 4138224; 101/860/085CZ, Lot Number 4165743; 101/860/085CZ, Lot Number 4177836; 101/860/085CZ, Lot Number 4197019; 101/860/085CZ, Lot Number 4205591; 101/860/085CZ, Lot Number 4214079; 101/860/085CZ, Lot Number 4238235; 101/860/085CZ, Lot Number 4249237; 101/860/085CZ, Lot Number 4256364; 101/860/085CZ, Lot Number 4270940; 101/860/085CZ, Lot Number 4310532; 101/860/085CZ, Lot Number 4368644; 101/860/085CZ, Lot Number 4382005; 101/860/090CZ, Lot Number 3895091; 101/860/090CZ, Lot Number 3914422; 101/860/090CZ, Lot Number 3951202; 101/860/090CZ, Lot Number 3954853; 101/860/090CZ, Lot Number 3989279; 101/860/090CZ, Lot Number 4009810; 101/860/090CZ, Lot Number 4017242; 101/860/090CZ, Lot Number 4030604; 101/860/090CZ, Lot Number 4037924; 101/860/090CZ, Lot Number 4058605; 101/860/090CZ, Lot Number 4071183; 101/860/090CZ, Lot Number 4100371; 101/860/090CZ, Lot Number 4103825; 101/860/090CZ, Lot Number 4117879; 101/860/090CZ, Lot Number 4124564; 101/860/090CZ, Lot Number 4134881; 101/860/090CZ, Lot Number 4138175; 101/860/090CZ, Lot Number 4183964; 101/860/090CZ, Lot Number 4183965; 101/860/090CZ, Lot Number 4191506; 101/860/090CZ, Lot Number 4199354; 101/860/090CZ, Lot Number 4209002; 101/860/090CZ, Lot Number 4232675; 101/860/090CZ, Lot Number 4239848; 101/860/090CZ, Lot Number 4249235; 101/860/090CZ, Lot Number 4252466; 101/860/090CZ, Lot Number 4276630; 101/860/090CZ, Lot Number 4285839; 101/860/090CZ, Lot Number 4306063; 101/860/090CZ, Lot Number 4306064; 101/860/090CZ, Lot Number 4310533; 101/860/090CZ, Lot Number 4382009; 101/860/090CZ, Lot Number 4385029; 101/860/100CZ, Lot Number 3895093; 101/860/100CZ, Lot Number 3925786; 101/860/100CZ, Lot Number 3951305; 101/860/100CZ, Lot Number 3968281; 101/860/100CZ, Lot Number 4010004; 101/860/100CZ, Lot Number 4025595; 101/860/100CZ, Lot Number 4054789; 101/860/100CZ, Lot Number 4199355; 101/860/100CZ, Lot Number 4217881; 101/860/100CZ, Lot Number 4285765; 101/860/100CZ, Lot Number 4412135; 101/870/060CZ, Lot Number 3887510; 101/870/060CZ, Lot Number 3925734; 101/870/060CZ, Lot Number 3951306; 101/870/060CZ, Lot Number 4031337; 101/870/060CZ, Lot Number 4106745; 101/870/060CZ, Lot Number 4217882; 101/870/070CZ, Lot Number 3889311; 101/870/070CZ, Lot Number 3951204; 101/870/070CZ, Lot Number 3968404; 101/870/070CZ, Lot Number 4017237; 101/870/070CZ, Lot Number 4022711; 101/870/070CZ, Lot Number 4034792; 101/870/070CZ, Lot Number 4058662; 101/870/070CZ, Lot Number 4073762; 101/870/070CZ, Lot Number 4134828; 101/870/070CZ, Lot Number 4138214; 101/870/070CZ, Lot Number 4156953; 101/870/070CZ, Lot Number 4165744; 101/870/070CZ, Lot Number 4178001; 101/870/070CZ, Lot Number 4217826; 101/870/070CZ, Lot Number 4249291; 101/870/070CZ, Lot Number 4256336; 101/870/070CZ, Lot Number 4283719; 101/870/070CZ, Lot Number 4291171; 101/870/075CZ, Lot Number 3906881; 101/870/075CZ, Lot Number 3951207; 101/870/075CZ, Lot Number 3968405; 101/870/075CZ, Lot Number 4054813; 101/870/075CZ, Lot Number 4058606; 101/870/075CZ, Lot Number 4061022; 101/870/075CZ, Lot Number 4134829; 101/870/075CZ, Lot Number 4138176; 101/870/075CZ, Lot Number 4183954; 101/870/075CZ, Lot Number 4212004; 101/870/075CZ, Lot Number 4238185; 101/870/075CZ, Lot Number 4249236; 101/870/075CZ, Lot Number 4270941; 101/870/075CZ, Lot Number 4276631; 101/870/075CZ, Lot Number 4382010; 101/870/080CZ, Lot Number 3887515; 101/870/080CZ, Lot Number 3951288; 101/870/080CZ, Lot Number 3980351; 101/870/080CZ, Lot Number 3989180; 101/870/080CZ, Lot Number 4017250; 101/870/080CZ, Lot Number 4051928; 101/870/080CZ, Lot Number 4054796; 101/870/080CZ, Lot Number 4070522; 101/870/080CZ, Lot Number 4117931; 101/870/080CZ, Lot Number 4134866; 101/870/080CZ, Lot Number 4138056; 101/870/080CZ, Lot Number 4156930; 101/870/080CZ, Lot Number 4163106; 101/870/080CZ, Lot Number 4208997; 101/870/080CZ, Lot Number 4238168; 101/870/080CZ, Lot Number 4254564; 101/870/080CZ, Lot Number 4303380; 101/870/080CZ, Lot Number 4310523; 101/870/080CZ, Lot Number 4312285; 101/870/080CZ, Lot Number 4317581; 101/870/080CZ, Lot Number 4319800; 101/870/080CZ, Lot Number 4368642; 101/870/080CZ, Lot Number 4388736; 101/870/080CZ, Lot Number 4390747; 101/870/085CZ, Lot Number 3887484; 101/870/085CZ, Lot Number 3925788; 101/870/085CZ, Lot Number 4002986; 101/870/085CZ, Lot Number 4054842; 101/870/085CZ, Lot Number 4085217; 101/870/085CZ, Lot Number 4110784; 101/870/085CZ, Lot Number 4121517; 101/870/085CZ, Lot Number 4156983; 101/870/085CZ, Lot Number 4183981; 101/870/085CZ, Lot Number 4212070; 101/870/085CZ, Lot Number 4245285; 101/870/085CZ, Lot Number 4249238; 101/870/085CZ, Lot Number 4376585; 101/870/090CZ, Lot Number 3892136; 101/870/090CZ, Lot Number 3907683; 101/870/090CZ, Lot Number 3951191; 101/870/090CZ, Lot Number 3962340; 101/870/090CZ, Lot Number 4000188; 101/870/090CZ, Lot Number 4061185; 101/870/090CZ, Lot Number 4075797; 101/870/090CZ, Lot Number 4106832; 101/870/090CZ, Lot Number 4129451; 101/870/090CZ, Lot Number 4138105; 101/870/090CZ, Lot Number 4155508; 101/870/090CZ, Lot Number 4178002; 101/870/090CZ, Lot Number 4183974; 101/870/090CZ, Lot Number 4242948; 101/870/090CZ, Lot Number 4249307; 101/870/090CZ, Lot Number 4249334; 101/870/090CZ, Lot Number 4276656; 101/870/090CZ, Lot Number 4285763; 101/870/090CZ, Lot Number 4285764; 101/870/090CZ, Lot Number 4303381; 101/870/090CZ, Lot Number 4387367; 101/870/100CZ, Lot Number 3887465; 101/870/100CZ, Lot Number 3925771; 101/870/100CZ, Lot Number 3996000; 101/870/100CZ, Lot Number 4075798; 101/870/100CZ, Lot Number 4087868; 101/870/100CZ, Lot Number 4106718; 101/870/100CZ, Lot Number 4209008; 101/870/100CZ, Lot Number 4217806; 101/870/100CZ, Lot Number 4245461; 101/870/100CZ, Lot Number 4256343; 101/870/100CZ, Lot Number 4306010; 101/875/060, Lot Number 3973580; 101/875/060, Lot Number 3994206; 101/875/060, Lot Number 4077390; 101/875/060, Lot Number 4077409; 101/875/060, Lot Number 4097405; 101/875/060, Lot Number 4106652; 101/875/060, Lot Number 4121852; 101/875/060, Lot Number 4174792; 101/875/060, Lot Number 4185328; 101/875/060, Lot Number 4228918; 101/875/060, Lot Number 4294942; 101/875/060, Lot Number 4306861; 101/875/070, Lot Number 3965241; 101/875/070, Lot Number 3997476; 101/875/070, Lot Number 4040743; 101/875/070, Lot Number 4040744; 101/875/070, Lot Number 4040748; 101/875/070, Lot Number 4083147; 101/875/070, Lot Number 4090267; 101/875/070, Lot Number 4106653; 101/875/070, Lot Number 4106657; 101/875/070, Lot Number 4130528; 101/875/070, Lot Number 4219470; 101/875/070, Lot Number 4244044; 101/875/070, Lot Number 4244045; 101/875/075, Lot Number 3956207; 101/875/075, Lot Number 3965238; 101/875/075, Lot Number 4106984; 101/875/075, Lot Number 4230803; 101/875/075, Lot Number 4294936; 101/875/075, Lot Number 4318743; 101/875/075, Lot Number 4380983; 101/875/080, Lot Number 3905060; 101/875/080, Lot Number 4038638; 101/875/080, Lot Number 4071393; 101/875/080, Lot Number 4083162; 101/875/080, Lot Number 4088887; 101/875/080, Lot Number 4091522; 101/875/080, Lot Number 4106655; 101/875/080, Lot Number 4124771; 101/875/080, Lot Number 4187079; 101/875/080, Lot Number 4187084; 101/875/080, Lot Number 4202304; 101/875/080, Lot Number 4220404; 101/875/080, Lot Number 4279527; 101/875/080, Lot Number 4294941; 101/875/080, Lot Number 4375952; 101/875/085, Lot Number 3956339; 101/875/085, Lot Number 4106981; 101/875/085, Lot Number 4119879; 101/875/085, Lot Number 4187077; 101/875/085, Lot Number 4202297; 101/875/085, Lot Number 4216554; 101/875/090, Lot Number 4034431; 101/875/090, Lot Number 4067217; 101/875/090, Lot Number 4068186; 101/875/090, Lot Number 4106650; 101/875/090, Lot Number 4106999; 101/875/090, Lot Number 4115631; 101/875/090, Lot Number 4118290; 101/875/090, Lot Number 4187086; 101/875/090, Lot Number 4206467; 101/875/090, Lot Number 4216550; 101/875/090, Lot Number 4220407; 101/875/100, Lot Number 3905062

Distribution pattern

Worldwide

device · product 2 of 3

smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

Z-3087-2024
Recall number
Z-3087-2024
Initiated
June 07, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
12234 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

101/540/080, Lot Number 3943992; 101/540/080, Lot Number 4258998; 101/540/090, Lot Number 4309778; 101/541/070, Lot Number 3887542; 101/541/070, Lot Number 3913366; 101/541/070, Lot Number 4202486; 101/541/070, Lot Number 4350937; 101/541/080, Lot Number 3887517; 101/541/080, Lot Number 3910324; 101/541/080, Lot Number 3912758; 101/541/080, Lot Number 4170885; 101/541/080, Lot Number 4184037; 101/541/080, Lot Number 4310310; 101/541/080, Lot Number 4312324; 101/541/080, Lot Number 4332049; 101/541/080, Lot Number 4332050; 101/541/090, Lot Number 3887526; 101/541/090, Lot Number 3925818; 101/541/090, Lot Number 4234865; 101/541/090, Lot Number 4266477; 101/541/090, Lot Number 4310313; 101/543/070, Lot Number 3887541; 101/543/070, Lot Number 4310304; 101/543/080, Lot Number 3887527; 101/543/080, Lot Number 3910325; 101/543/080, Lot Number 4310447; 101/543/080, Lot Number 4332051; 101/543/080, Lot Number 4332052; 101/543/080, Lot Number 4332053; 101/543/080, Lot Number 4332054; 101/543/080, Lot Number 4382017; 101/543/080, Lot Number 4382018; 101/543/080, Lot Number 4382019; 101/543/080, Lot Number 4382020; 101/543/080, Lot Number 4382021; 101/543/080, Lot Number 4382022; 101/543/080, Lot Number 4382023; 101/543/080, Lot Number 4382024; 101/543/080, Lot Number 4382025; 101/543/090, Lot Number 3887518; 101/543/090, Lot Number 4384983; 101/891/070, Lot Number 3910414; 101/891/070, Lot Number 3925816; 101/891/070, Lot Number 4117953; 101/891/070, Lot Number 4156869; 101/891/070, Lot Number 4205521; 101/891/070, Lot Number 4232678; 101/891/080, Lot Number 3887523; 101/891/080, Lot Number 3896997; 101/891/080, Lot Number 3896998; 101/891/080, Lot Number 4306752; 101/891/080, Lot Number 4388711; 101/891/090, Lot Number 3913655; 101/891/090, Lot Number 3925770; 101/891/090, Lot Number 4005342; 101/891/090, Lot Number 4310412; 101/892/070, Lot Number 3950087; 101/892/080, Lot Number 3943993; 101/892/080, Lot Number 4165114; 101/892/080, Lot Number 4226926; 101/892/090, Lot Number 3944020; 101/892/090, Lot Number 4194294; 101/893/070, Lot Number 3925807; 101/893/070, Lot Number 4005284; 101/893/070, Lot Number 4005285; 101/893/070, Lot Number 4089723; 101/893/070, Lot Number 4117954; 101/893/070, Lot Number 4138223; 101/893/070, Lot Number 4189353; 101/893/070, Lot Number 4270948; 101/893/070, Lot Number 4281033; 101/893/080, Lot Number 3910326; 101/893/080, Lot Number 3912757; 101/893/080, Lot Number 4005351; 101/893/080, Lot Number 4010052; 101/893/080, Lot Number 4070524; 101/893/080, Lot Number 4165747; 101/893/080, Lot Number 4205522; 101/893/080, Lot Number 4238251; 101/893/080, Lot Number 4281154; 101/893/080, Lot Number 4281202; 101/893/080, Lot Number 4285878; 101/893/080, Lot Number 4289001; 101/893/080, Lot Number 4310416; 101/893/080, Lot Number 4310417; 101/893/080, Lot Number 4310418; 101/893/080, Lot Number 4310419; 101/893/080, Lot Number 4343143; 101/893/080, Lot Number 4382056; 101/893/080, Lot Number 4382057; 101/893/080, Lot Number 4382058; 101/893/080, Lot Number 4382059; 101/893/080, Lot Number 4382060; 101/893/080, Lot Number 4382061; 101/893/090, Lot Number 3925810; 101/893/090, Lot Number 4177907; 101/893/090, Lot Number 4310430; 101/893/090, Lot Number 4310431; 101/893/090, Lot Number 4310432; 101/893/090, Lot Number 4310433; 101/893/090, Lot Number 4310434; 101/893/090, Lot Number 4310435

Distribution pattern

Worldwide

device · product 3 of 3

smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090; 4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070; 5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080; 6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090; 7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070; 8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080; 9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090; 10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070; 11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080; 12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090

Z-3088-2024
Recall number
Z-3088-2024
Initiated
June 07, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
41691 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

101/561/070, Lot Number 3887555; 101/561/070, Lot Number 3928959; 101/561/070, Lot Number 4005346; 101/561/070, Lot Number 4217858; 101/561/070, Lot Number 4234862; 101/561/070, Lot Number 4266405; 101/561/070, Lot Number 4348810; 101/561/080, Lot Number 3887536; 101/561/080, Lot Number 3906566; 101/561/080, Lot Number 3906567; 101/561/080, Lot Number 3906568; 101/561/080, Lot Number 4217859; 101/561/080, Lot Number 4232677; 101/561/080, Lot Number 4238252; 101/561/080, Lot Number 4249230; 101/561/080, Lot Number 4281149; 101/561/080, Lot Number 4281150; 101/561/080, Lot Number 4283700; 101/561/080, Lot Number 4285877; 101/561/080, Lot Number 4288974; 101/561/080, Lot Number 4291189; 101/561/080, Lot Number 4304152; 101/561/080, Lot Number 4308334; 101/561/080, Lot Number 4348877; 101/561/080, Lot Number 4348878; 101/561/080, Lot Number 4348879; 101/561/080, Lot Number 4348883; 101/561/080, Lot Number 4348884; 101/561/080, Lot Number 4348885; 101/561/080, Lot Number 4348886; 101/561/080, Lot Number 4348892; 101/561/080, Lot Number 4348893; 101/561/080, Lot Number 4382035; 101/561/080, Lot Number 4382036; 101/561/080, Lot Number 4382037; 101/561/080, Lot Number 4382038; 101/561/080, Lot Number 4382039; 101/561/080, Lot Number 4382040; 101/561/080, Lot Number 4386515; 101/561/080, Lot Number 4386516; 101/561/080, Lot Number 4386517; 101/561/080, Lot Number 4386518; 101/561/080, Lot Number 4396543; 101/561/080, Lot Number 4396544; 101/561/080, Lot Number 4396545; 101/561/080, Lot Number 4399795; 101/561/080, Lot Number 4399796; 101/561/080, Lot Number 4399797; 101/561/080, Lot Number 4399798; 101/561/080, Lot Number 4399799; 101/561/080, Lot Number 4405137; 101/561/080, Lot Number 4408626; 101/561/080, Lot Number 4412102; 101/561/080, Lot Number 4412103; 101/561/080, Lot Number 4412104; 101/561/080, Lot Number 4415777; 101/561/080, Lot Number 4415778; 101/561/080, Lot Number 4415785; 101/561/090, Lot Number 3887528; 101/561/090, Lot Number 3928993; 101/561/090, Lot Number 3976736; 101/561/090, Lot Number 4170968; 101/561/090, Lot Number 4205592; 101/561/090, Lot Number 4234863; 101/561/090, Lot Number 4242949; 101/561/090, Lot Number 4281078; 101/561/090, Lot Number 4285761; 101/561/090, Lot Number 4310484; 101/561/090, Lot Number 4310485; 101/561/090, Lot Number 4310486; 101/561/090, Lot Number 4310487; 101/561/090, Lot Number 4310488; 101/561/090, Lot Number 4382032; 101/561/090, Lot Number 4382034; 101/561/090, Lot Number 4397559; 101/561/090, Lot Number 4397560; 101/561/090, Lot Number 4415811; 101/561/090, Lot Number 4439066; 101/561/090, Lot Number 4450465; 101/563/070, Lot Number 3887520; 101/563/070, Lot Number 3925814; 101/563/070, Lot Number 3948836; 101/563/070, Lot Number 3965003; 101/563/070, Lot Number 4010058; 101/563/070, Lot Number 4017238; 101/563/070, Lot Number 4054722; 101/563/070, Lot Number 4054723; 101/563/070, Lot Number 4054801; 101/563/070, Lot Number 4165746; 101/563/070, Lot Number 4234758; 101/563/070, Lot Number 4245279; 101/563/070, Lot Number 4249227; 101/563/070, Lot Number 4281148; 101/563/080, Lot Number 3887521; 101/563/080, Lot Number 3910412; 101/563/080, Lot Number 3925815; 101/563/080, Lot Number 3952030; 101/563/080, Lot Number 4009963; 101/563/080, Lot Number 4054725; 101/563/080, Lot Number 4054726; 101/563/080, Lot Number 4061095; 101/563/080, Lot Number 4070503; 101/563/080, Lot Number 4070504; 101/563/080, Lot Number 4073772; 101/563/080, Lot Number 4100287; 101/563/080, Lot Number 4100288; 101/563/080, Lot Number 4103806; 101/563/080, Lot Number 4115434; 101/563/080, Lot Number 4147040; 101/563/080, Lot Number 4149715; 101/563/080, Lot Number 4156960; 101/563/080, Lot Number 4175503; 101/563/080, Lot Number 4199278; 101/563/080, Lot Number 4205593; 101/563/080, Lot Number 4208994; 101/563/080, Lot Number 4217863; 101/563/080, Lot Number 4224557; 101/563/080, Lot Number 4234759; 101/563/080, Lot Number 4281042; 101/563/080, Lot Number 4283716; 101/563/080, Lot Number 4283717; 101/563/080, Lot Number 4283718; 101/563/080, Lot Number 4285933; 101/563/080, Lot Number 4285934; 101/563/080, Lot Number 4285935; 101/563/080, Lot Number 4285936; 101/563/080, Lot Number 4348839; 101/563/080, Lot Number 4348840; 101/563/080, Lot Number 4348841; 101/563/080, Lot Number 4348845; 101/563/080, Lot Number 4348847; 101/563/080, Lot Number 4348848; 101/563/080, Lot Number 4348849; 101/563/080, Lot Number 4348850; 101/563/080, Lot Number 4348851; 101/563/080, Lot Number 4348857; 101/563/080, Lot Number 4348858; 101/563/080, Lot Number 4348859; 101/563/080, Lot Number 4348860; 101/563/080, Lot Number 4350944; 101/563/080, Lot Number 4350945; 101/563/080, Lot Number 4354160; 101/563/080, Lot Number 4385041; 101/563/080, Lot Number 4385042; 101/563/080, Lot Number 4385043; 101/563/080, Lot Number 4385046; 101/563/080, Lot Number 4385047; 101/563/080, Lot Number 4385048; 101/563/080, Lot Number 4385049; 101/563/080, Lot Number 4385050; 101/563/080, Lot Number 4385051; 101/563/080, Lot Number 4385052; 101/563/080, Lot Number 4396414; 101/563/080, Lot Number 4396415; 101/563/080, Lot Number 4396416; 101/563/080, Lot Number 4396419; 101/563/080, Lot Number 4396420; 101/563/080, Lot Number 4396534; 101/563/080, Lot Number 4396535; 101/563/080, Lot Number 4396536; 101/563/080, Lot Number 4396537; 101/563/090, Lot Number 3913653; 101/563/090, Lot Number 3925768; 101/563/090, Lot Number 3980266; 101/563/090, Lot Number 4009974; 101/563/090, Lot Number 4061111; 101/563/090, Lot Number 4094349; 101/563/090, Lot Number 4106839; 101/563/090, Lot Number 4115435; 101/563/090, Lot Number 4156962; 101/563/090, Lot Number 4170970; 101/563/090, Lot Number 4212065; 101/563/090, Lot Number 4227249; 101/563/090, Lot Number 4238178; 101/563/090, Lot Number 4281031; 101/563/090, Lot Number 4348865; 101/563/090, Lot Number 4348866; 101/563/090, Lot Number 4348867; 101/563/090, Lot Number 4386559; 101/563/090, Lot Number 4408641; 101/563/090, Lot Number 4412148; 101/595/070, Lot Number 3898766; 101/595/070, Lot Number 4002180; 101/595/070, Lot Number 4008828; 101/595/070, Lot Number 4032081; 101/595/070, Lot Number 4060523; 101/595/070, Lot Number 4086681; 101/595/070, Lot Number 4168564; 101/595/070, Lot Number 4234424; 101/595/070, Lot Number 4242669; 101/595/070, Lot Number 4256056; 101/595/070, Lot Number 4280697; 101/595/070, Lot Number 4293992; 101/595/070, Lot Number 4324235; 101/595/070, Lot Number 4333064; 101/595/070, Lot Number 4352941; 101/595/070, Lot Number 4415588; 101/595/070, Lot Number 4415609; 101/595/070, Lot Number 4423960; 101/595/080, Lot Number 3898767; 101/595/080, Lot Number 3950077; 101/595/080, Lot Number 3950078; 101/595/080, Lot Number 3987811; 101/595/080, Lot Number 3991671; 101/595/080, Lot Number 4008820; 101/595/080, Lot Number 4032077; 101/595/080, Lot Number 4032079; 101/595/080, Lot Number 4060526; 101/595/080, Lot Number 4072732; 101/595/080, Lot Number 4086680; 101/595/080, Lot Number 4098486; 101/595/080, Lot Number 4110835; 101/595/080, Lot Number 4128476; 101/595/080, Lot Number 4131412; 101/595/080, Lot Number 4148995; 101/595/080, Lot Number 4163147; 101/595/080, Lot Number 4179977; 101/595/080, Lot Number 4256035; 101/595/080, Lot Number 4259012; 101/595/080, Lot Number 4265777; 101/595/080, Lot Number 4272986; 101/595/080, Lot Number 4283836; 101/595/080, Lot Number 4296804; 101/595/080, Lot Number 4324236; 101/595/080, Lot Number 4326879; 101/595/080, Lot Number 4330616; 101/595/080, Lot Number 4339190; 101/595/080, Lot Number 4341351; 101/595/080, Lot Number 4425478; 101/595/090, Lot Number 3898768; 101/595/090, Lot Number 3944042; 101/595/090, Lot Number 3950056; 101/595/090, Lot Number 3987809; 101/595/090, Lot Number 4008834; 101/595/090, Lot Number 4008836; 101/595/090, Lot Number 4036473; 101/595/090, Lot Number 4036503; 101/595/090, Lot Number 4060529; 101/595/090, Lot Number 4098459; 101/595/090, Lot Number 4110836; 101/595/090, Lot Number 4168614; 101/595/090, Lot Number 4177105; 101/595/090, Lot Number 4183504; 101/595/090, Lot Number 4263406; 101/595/090, Lot Number 4265778; 101/595/090, Lot Number 4291330; 101/595/090, Lot Number 4294002; 101/595/090, Lot Number 4324771; 101/595/090, Lot Number 4330618; 101/595/090, Lot Number 4344183; 101/595/090, Lot Number 4423957; 101/596/070, Lot Number 3944058; 101/596/070, Lot Number 3967805; 101/596/070, Lot Number 4008830; 101/596/070, Lot Number 4060560; 101/596/070, Lot Number 4098464; 101/596/070, Lot Number 4116821; 101/596/070, Lot Number 4123503; 101/596/070, Lot Number 4134674; 101/596/070, Lot Number 4240514; 101/596/070, Lot Number 4241327; 101/596/070, Lot Number 4263399; 101/596/070, Lot Number 4275910; 101/596/070, Lot Number 4285358; 101/596/070, Lot Number 4415589; 101/596/070, Lot Number 4423966; 101/596/070, Lot Number 4428303; 101/596/080, Lot Number 3898770; 101/596/080, Lot Number 3979602; 101/596/080, Lot Number 3979615; 101/596/080, Lot Number 4008832; 101/596/080, Lot Number 4036527; 101/596/080, Lot Number 4060531; 101/596/080, Lot Number 4069871; 101/596/080, Lot Number 4101970; 101/596/080, Lot Number 4110837; 101/596/080, Lot Number 4119536; 101/596/080, Lot Number 4131437; 101/596/080, Lot Number 4146207; 101/596/080, Lot Number 4179935; 101/596/080, Lot Number 4241328; 101/596/080, Lot Number 4246523; 101/596/080, Lot Number 4252236; 101/596/080, Lot Number 4256036; 101/596/080, Lot Number 4268459; 101/596/080, Lot Number 4307794; 101/596/080, Lot Number 4415596; 101/596/080, Lot Number 4436549; 101/596/090, Lot Number 3944050; 101/596/090, Lot Number 3950088; 101/596/090, Lot Number 4008815; 101/596/090, Lot Number 4032080; 101/596/090, Lot Number 4060533; 101/596/090, Lot Number 4098449; 101/596/090, Lot Number 4101971; 101/596/090, Lot Number 4119537; 101/596/090, Lot Number 4123504; 101/596/090, Lot Number 4261158; 101/596/090, Lot Number 4263403; 101/596/090, Lot Number 4270589; 101/596/090, Lot Number 4280743; 101/596/090, Lot Number 4285393; 101/596/090, Lot Number 4301196; 101/596/090, Lot Number 4319347; 101/596/090, Lot Number 4326871; 101/596/090, Lot Number 4423968; 101/596/090, Lot Number 4436550; 101/596/090, Lot Number 4447674; 101/596/090, Lot Number 4459709

Distribution pattern

Worldwide