Trade name: Sheath Prelude Introducer with Needle. Technical name: Introducers. ANVISA registration number: 80740950022. Class of risk: II. Model Affected: PSI-4F-11-018; PSI-4F-11-035; PSI-4F-7-018; PSI-5F-11-018; PSI-5F-7-018; PSI-6F-11-018; PSI-6F-11-035; PSI-6F-23-038; PSI-8F-23-035 .. Serial numbers affected: H802104; H806589; H806563; H829231; H869123; H848212; H861337; H910848; H835834; H869107; H916892; H957657; H964183; H957686; H964253; H985394; H985395; H998662; H998663; H985268; H985169; H971709; H978333; H957674; H991436; H1005204; H1005185; H1005186; H998648; H1014767; H1021017; H1028215; H1021246; H1041894; H888879; H978383; H1028221; H1035120; H1035143; H1035145; H1049148; H964219; H1049127; H1086779; H1064319; H1049137; H1071895; H1117323; H1117324; H1064320; H1070592; H1070597; H1117325; H1102033; H1101832; H1117326; H1125976; H1028219; H1101833; H1133413; H1109361; H1133441; H1117248; H1056694