Z-3087-2024 Class I Ongoing

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

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.

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