FDA Device Recall Z-3088-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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

Quantity: 41691 units

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.

Recall record

Recall number: Z-3088-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2024-06-07
Classified by FDA Center: 2024-09-11
FDA published: 2024-09-18
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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