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

Recall details

Manufacturer

Smiths Medical ASD Inc.

Distributor

Worldwide

Lot

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 Numbe

Risk classification

Class I

Area (FDA)

device

Country

United States