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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow TwoLumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter

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 Class 1 Device Recall Arrow TwoLumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter see related information
Date Posted June 26, 2012
Recall Status1 Terminated on March 22, 2013
Recall Number Z-1830-2012
Recall Event ID 61915
510(K)Number K900263 
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product 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.
Code Information 1068068, ZF1079360, ZF1091810, ZF1124738, and ZF2016135.

PN BERGAMO-25703-E -- lots ZF1013935, ZF1025164, ZF1080637, and ZF2016301.

PN BERGAMO-27702-E -- lots ZF1068066, ZF1068387, ZF1079362, and ZF2016323.

PN BK-22703 -- lots ZF0099250, ZF0100825, ZF0112082, ZF1013641, ZF1024588, ZF1025250, ZF1047624, ZF1079593, and ZF1125034.

PN BL-22702 -- lots ZF1091516, ZF1092045, ZF1103065, ZF1114379, and ZF2017014.

PN BL-22703 -- lots ZF1091518, ZF1092078, ZF1103088, and ZF2016667.

PN BO-25854 -- lots ZF1013696, ZF1024907, ZF1035642, ZF1036534, ZF1047328, and ZF1079344.

PN BR-20854 -- lots ZF1125061 and ZF2016643.

PN BR-22703 -- lots ZF0099252, ZF0111422, ZF1024366, ZF1035761, ZF1056835, ZF1068646, ZF1079595, ZF1103344, and ZF1114246.

PN BR-22853 -- lots ZF0088532, ZF0122487, ZF1013692, ZF1036027, ZF1068392, ZF1079024, ZF1092015, ZF1103238, and ZF1113994.

PN BR-22854 -- lots ZF0088530, ZF0099244, ZF0100823, ZF0111420, ZF0112135, ZF0122421, ZF1013151, ZF1013694, ZF1035334, ZF1046572, ZF1047377, ZF1057193, ZF1068395, ZF1068730, ZF1079839, ZF1090989, ZF1091659, ZF1102184, ZF1102904, ZF1103178, ZF1113451, ZF1125247, ZF2015904, ZF2016516, and ZF2016861.

PN BR-24703 -- lots ZF0088640, ZF0099165, ZF0099618, ZF0099896, ZF0100767, ZF0101051, ZF0111518, ZF0111767, ZF0112208, ZF0122625, ZF1013344, ZF1024591, ZF1024820, ZF1036037, ZF1036306, ZF1047078, ZF1047554, ZF1056688, ZF1057083, ZF1068061, ZF1068894, ZF1079530, ZF1080027, ZF1080304, ZF1080635, ZF1091270, ZF1113410, and ZF1114269.

PN BR-25703 -- lots ZF0100947, ZF1080794, and ZF2016824.

PN BR-25854 -- lots ZF0066888, ZF0088996, ZF0099430, ZF0100330, ZF0100802, ZF0111400, ZF0112163, ZF0122889, ZF1013698, ZF1024906, ZF1036536, ZF1047354, ZF1056910, ZF1068230, ZF1068576, ZF1079347, ZF1080650, ZF1102299, ZF1113582, ZF1114124, ZF1125398, ZF2015914, and ZF2016245.

PN BU-25703-E -- lots ZF0099201, ZF0099925, ZF0100816, ZF0111610, ZF0123118, ZF1013931, ZF1024342, ZF1024782, ZF1047099, ZF1057196, ZF1057710, ZF1079144, ZF1080801, ZF1089961, ZF1091219, ZF1102338, ZF1103226, ZF1113505, and ZF2016027.

PN CH-24701-H -- lots ZF1091039 and ZF1102281.

PN CH-45703-H -- lots ZF1091043 and ZF2016040.

PN CH-45854-H -- lots ZF1091037, ZF1102279, and ZF2016053.

PN CH-47702-H -- lots ZF1091041 and ZF2016076.

PN COMO-27702 -- lots ZF1014147, ZF1025033, ZF1036382, ZF1057098, ZF1068866, and ZF1079452.

PN CS-22122-F -- lots ZF0100435, ZF0101091, ZF0111721, ZF0122377, ZF0122774, ZF1014230, ZF1024705, ZF1024966, ZF1025265, ZF1035799, ZF1036198, ZF1046751, ZF1047254, ZF1056804, ZF1057596, ZF1079753, ZF1090912, ZF1102738, ZF1114074, ZF1114663, ZF1124881, ZF1125074, and ZF2016125.

PN CS-22123-F -- lots ZF0111725, ZF0122380, ZF0122780, ZF1013593, ZF1013817, ZF1024974, ZF1024975, ZF1035800, ZF1035801, ZF1047258, ZF1057233, ZF1057861, ZF1068676, ZF1079389, ZF1079766, ZF1080049, ZF1091528, ZF1091921, ZF1102134, ZF1102135, ZF1102736, ZF1102737, ZF1103117, ZF1103118, ZF1113794, ZF1114286, ZF1124705, ZF1124877, ZF1125076, and ZF2016809.

PN CS- 22802 -- lots ZF1025273, ZF1036224, ZF1047627, ZF1047628, ZF1068415, ZF1079652, ZF1080423, ZF1091399, ZF1091656, ZF1091947, ZF1102887, ZF1103185, ZF1114099, ZF1114316, and ZF2016846.

PN CS-22855 -- lots ZF0111621, ZF0122512, ZF0122832, ZF1013766, ZF1024932, ZF1035653, ZF1035654, ZF1036226, ZF1047335, ZF1057264, ZF1057859, ZF1068052, ZF1078999, ZF1080144, ZF1080653, ZF1090966, ZF1091493, ZF1091692, ZF1091914, ZF1102127, ZF1102418, ZF1102811, ZF1103111, ZF1113413, ZF1114530, ZF2016805, and ZF2017180.

PN CS-25122-F -- lots ZF0122321 ZF1080697, ZF1013590, ZF1014226, ZF1024704, ZF1024976, ZF1035651, ZF1035803, ZF1047263, ZF1057253, ZF1057595, ZF1079582, ZF1080052, ZF1090913, ZF1090914, ZF1091164, ZF1091963, ZF1102170, ZF1102457, ZF1102852, ZF1113436, ZF1113788, ZF1114051, ZF1114532, ZF1124820, ZF1125472, ZF2016122, and ZF2016798.

PN CS-25123-E -- lots ZF1024978, ZF1036334, ZF1047261, ZF1056803, ZF1057856, ZF1079583, ZF10
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall
Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
FDA Determined
Cause 2
Labeling mix-ups
Action Arrow International sent an Urgent Field Corrective Action letter dated May 3, 2012 to their US consignee. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to quarantine any affected inventory and relay the information to their Arrow Sales Representative. The letter stated that the Arrow Sales Representative would affix new labels to each kit within their inventory. The consignee was instructed to sign the Acknowledgement Form provided by the Sales Representative which would then be submitted to Arrow. An Urgent Field Safety Notice letter dated May 15, 2012 was sent to foreign consignees with field safety corrective action instructions to follow. If you require additional information or clarification regarding this matter contact your sales representative.
Quantity in Commerce 634,912
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTL., INC.
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