Trade name: Sheath Prelude Introducer with Needle. Technical name: Introducers. ANVISA registration number: 80740950020. Risk class: II. Model Affected: PSI-5F-11-035-18G; PSI-5F-11-038-18G; PSI-7F-11-035-18G; PSI-8F-11-035-18G; PSI-8F-11-038-18G .. Serial numbers affected: H775538; H790718; H802113; H806577; H812866; H822603; H822602; H806605; H829277; H835873; H822736; H767850; H829297; H788043; H790744; H852837; H829246; H841190; H669686; H724631; H830254; H886443; H829247; H835846; H848377; H802159; H955521; H829301; H874601; H890316; H900044; H916861; H943490; H950221; H964205; H971723; H978305; H924297; H950258; H957690; H964259; H998674; H900066; H910903; H985755; H991635; H835954; H998744; H975409; H1005212; H854282; H861401; H869136; H910866; H916920; H930913; H937371; H943513; H971741; H1005235; H965173; H995197; H1005194; H985356; H1005213; H1014823; H1014824; H1014825; H1014862; H991686; H1035163; H1041903; H1021289; H1028268; H1035198; H1021268; H1028266; H991512; H998657; H1021251; H1049236; H1041935; H1057258; H1067690; H1014784; H1049235; H1068880; H1068890; H1057247; H1021180; H1028228; H1068889; H1035126; H1035190; H1071870; H1079023; H1086800; H1086801; H1041928; H1078982; H1117256; H1101868; H971742; H1049249; H1133399; H1101867; H1117337; H1071899