Smiths Medical ASD Inc.: 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,

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: 799732 units Lot/code info: 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 4037

Source

Official record: FDA (Device enforcement) ↗

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