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FDAFDA · Food and drugs·Recall number Z-1830-2012

Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.

Published July 4, 2012 · Recall initiated: May 3, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Arrow International Inc
Distributor
Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HUNGARY, INDIA, ITALY, IRELAND, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, QATAR, R¿UNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TURKEY, UKRAINE, , UNITED ARAB EMIRATES and UNITED KINGDOM.
Lot
Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF1024535, ZF1025078, ZF1036034, ZF1036293, ZF1047553, ZF1068055, ZF1079398, ZF1080286, ZF1091018, ZF1102643, ZF1103235, ZF1113530, ZF1114129, ZF1114632, and ZF2016475. PN AD-24703-OB -- lots ZF1013508, ZF1024536, ZF1025079, ZF1036035, ZF1036449, ZF1057072, ZF1068314, ZF1079528, ZF1080288, ZF1080633, ZF1091019, ZF1092076, ZF1102574, ZF1124769, ZF1124963, ZF1125081, and ZF2016671. PN AD-24730-E -- lots ZF0111748, ZF0122465, ZF1013943, ZF1024429, ZF1035851, ZF1035852, ZF1046809, ZF1047095, ZF1056833, ZF1068324, ZF1068691, ZF1080036, ZF1080307, ZF1091021, ZF1102236, ZF1102876, ZF1113491, ZF1113853, ZF1114656, and ZF1125078. PN AD-24730-OB -- lots ZF0111749, ZF1013521, ZF1024545, ZF1035853, ZF1047096, ZF1056829, ZF1080032, ZF1091022, ZF1125298, ZF1125525, and ZF2016325. PN AD-24730-OL -- lots ZF1013523, ZF1024547, ZF1035855, ZF1056827, ZF1068325, ZF1068941, ZF1080034, ZF1102952, ZF1113498, ZF1114370, and ZF1125517. PN AD-24802 -- lots ZF1025245, ZF1046888, ZF1057494, ZF1068892, ZF1080134, ZF1091014, ZF1091171, ZF1091593, ZF1102950, ZF1113494, ZF1114114, ZF1125215, and ZF2015711. PN AD-24854 -- lots ZF1013537, ZF1024554, ZF1035413, ZF1036310, ZF1046999, ZF1047230, ZF1056918, ZF1057633, ZF1068902, ZF1079269, ZF1079743, ZF1091012, ZF1102545, ZF1103152, ZF1114358, ZF1125139, and ZF2015853. PN AD-24854-NL -- lots ZF1013534, ZF1013996, ZF1035415, ZF1036314, ZF1047232, ZF1056916, ZF1079745, ZF1080316, ZF1080521, and ZF1091239. PN AD-25703 -- lots ZF1013933, ZF1025162, ZF1035869, ZF1036227, ZF1046576, ZF1047364, ZF1068539, ZF1079142, ZF1079563, ZF1102242, ZF1102935, ZF1103232, ZF1113477, ZF1113861, ZF1114337, ZF1114661, and ZF2016129. PN AD-25802-OB -- lots ZF1035537, ZF1057086, ZF1068592, ZF1080274, ZF1080835, ZF1091595, ZF1092074, ZF1102288, ZF1102572, ZF1102786, ZF1125007, and ZF2016072. PN AD-25855 -- lots ZF1047288, ZF1057278, ZF1079689, and ZF1080527. PN AD-26702 -- lots ZF1014152, ZF1035785, ZF1047324, ZF1057505, ZF1079822, ZF1102346, ZF1102553, ZF1113647, ZF2016688, and ZF2016989. PN AG-25854-E -- lots ZF1047326 and ZF1068572. PN ARCS-22122-F -- lot ZF1025264. PN ARCS-22123-F -- lots ZF1025266 and ZF1036280. PN ARCS-22703-E -- lots ZF1025247, ZF1036221, and ZF2016691. PN ARCS-22802 -- lots ZF1025270 and ZF1057860. PN ARCS-22854-E -- lot ZF1035743. PN ARCS-22855 -- lots ZF1035652, ZF1036225, ZF1057858, ZF1102654, ZF1102996, ZF1113529, ZF1114218, ZF1114550, ZF1125252, ZF2015917, and ZF2016589. PN ARCS-25854-E -- lots ZF1025278, ZF1102290, ZF1114403, and ZF1125658. PN ARCS-25855 -- lots ZF1035590, ZF1036253, ZF1102514, and ZF1102997. PN ARCS-25855-E -- lots ZF1025280, ZF1036254, and ZF1102669. PN ARCS-26553 -- lot ZF1067964. PN ARCV-20854 -- lots ZF1025283, ZF1056834, ZF1056967, ZF1057598, ZF1068377, ZF1080368, ZF1102311, ZF1114239, ZF2015767, and ZF2016392. PN ARCV-22703 -- lot ZF1056968. PN ARCV-22854 -- lots ZF1025284, ZF1035655, ZF1056839, ZF1056840, ZF1091568, ZF1091752, ZF1091942, ZF1102158, ZF1102766, ZF1103070, ZF1113771, and ZF1113970. PN ARCV-25854 -- lots ZF1025279 and ZF1056841. PN AT-25854-E -- lots ZF0122759, ZF1013474, ZF1024278, ZF1024618, ZF1035555, ZF1057151, and ZF1079342. PN AT-25855 -- lots ZF1024383, ZF1068063, and ZF1079691. PN AT-25855-E -- lots ZF1013786, ZF1014215, ZF1025016, ZF1036255, ZF1047290, ZF1079687, ZF1080139, ZF1103336, and ZF1113583. PN BB-09903-AG -- lot ZF1035658. PN BB-22122-F -- lots ZF1024651 and ZF1125640. PN BB-22123-F -- lots ZF1013591, ZF1024972, ZF1036278, ZF1047255, ZF1057159, ZF1068380, ZF1079387, ZF1079764, ZF1090994, ZF1102569, ZF1102929, ZF1113525, ZF1113527, ZF1113896, ZF1125296, and ZF2027434. PN B-22853 -- lots ZF1024653, ZF1047631, and ZF1068048. PN BCV-27702-EJT -- lots ZF0090108, ZF0122703, ZF1025028, and ZF1091835. PN CV-27702-ENG -- lots ZF1025030, ZF1036006, ZF
Risk classification
Class I
Area (FDA)
device
Country
United States

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