Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Reason for recall: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". Distribution: Worldwide distribution - US Nationwide and the country of Panama. Quantity: 4500 units Lot/code info: a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; Lot Numbers: 23EBK088; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; Lot Numbers: 23EBT802; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; Lot Numbers: 23DBP964, 23CBU228; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; Lot Numbers: 23EBT909, 23EBG098, 23DBB838; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; Lot Numbers: 23EBU894; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; Lot Numbers: 23EDC133; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; Lot Numbers: 23EBX487; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; Lot Numbers: 23EMB984; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; Lot Numbers: 23EBU158, 23DBF885; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; Lot Numbers: 23EBG175, 23DBH412; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; Lot Numbers: 23EME586, 23DME845; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; Lot Numbers: 23EBR893; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; Lot Numbers: 23DMF789, 23CMD239; n) Model Number DYNJ63383, UDI/DI (EA
10195327343798, 40195327343799, 10195327074418, 40195327074419, 10195327195366, 40195327195367, 10195327135751, 40195327135752, 10195327135744, 40195327135745, 10195327156985, 40195327156986, 10193489958553, 40193489958554, 10193489340921, 40193489340922, 10195327102029, 40195327102020, 10193489910636, 40193489920637, 10193489395983, 40193489395984, 10193489257946, 40193489257947, 10195327295066, 40195327295067, 10193489735109, 40193489735100, 10195327112806, 40195327112807, 10193489236224, 40193489236225, 10195327177508, 40195327177509, 10195327256241, 40195327256242, 10193489996234, 40193489996235, 10195327097370, 40195327097371
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.