Smiths Medical ASD Inc.: smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit wi

Hazard

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.

Details from the source

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. Distribution: Worldwide Quantity: 41691 units Lot/code info: 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, Lo

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.