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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 , and ZF1102251.

PN EN-24730 -- lot ZF1056823.

PN EU-22703-IMIN -- ZF2016665.

PN EU-24701-EK -- ZF1046712 and ZF1102588.

PN EU-24702-EK -- lots ZF1057728, ZF1091859, ZF1114435, and ZF2016131.

PN EU-24703-CVT -- lots ZF0100776, ZF1102772, ZF1114552, ZF2015746, and ZF2016617.

PN EU-24703-EK -- lots ZF0090188, ZF0111762, ZF1013811, ZF1024322, ZF1024480, ZF1068834, ZF1080297, ZF1080780, ZF1091376, ZF1102565, and ZF1113589.

PN EU-24730-EK -- lots ZF1035857, ZF1056821, ZF1057722, ZF1068937, ZF1080305, ZF1080764, ZF1091875, ZF1103299, ZF1124735, and ZF1125511.

PN EU-25502-IMIN -- lot ZF1091128.

PN EU-25703-CVT -- lots ZF0100775, ZF0111411, ZF1025073, ZF1080177, ZF1113693, and ZF2016336.

PN EU-25703-EK -- lots ZF0100814, ZF1013925, ZF1036236, ZF1068782, ZF1091215, and ZF1102228.

PN EU-25703-IMIN -- lots ZF0078117, ZF0088688, ZF1102584, and ZF1124719.

PN UF-26702 -- lots ZF1046588, ZF1046660, ZF1057507, ZF1079826, ZF1080828, ZF1102249, ZF1102555, ZF1103379, and ZF1124750.

PN UW-24703-EK -- lots ZF1025110, ZF1035534, ZF1036055, ZF1036441, ZF1047189, ZF1056680, ZF1068826, ZF1079788, ZF1080770, ZF1102257, ZF1102559, and ZF1113539.

PN UW-24854-EK -- lots ZF1035419, ZF1035867, ZF1046997, ZF1047225, ZF1057325, ZF1068841, ZF1079263, ZF1079737, ZF1080308, ZF1080523, ZF1091766, ZF1102233, ZF1102774, ZF1125187, and ZF2015846.

PN UW-25855-EK -- lots ZF1035586, ZF1057663, ZF1079679, ZF1103312, and ZF1114223.

PN WR-24703 -- lots ZF0078206, ZF0099182, ZF0100951, ZF0111846, ZF0112191, ZF0122619, ZF1025108, ZF1036057, ZF1047081, ZF1047462, ZF1057268, ZF1079790, ZF1080290, ZF1091983, ZF1102846, and ZF1113818.

PN ZW-27702-J -- lots ZF1036406, ZF1056668, ZF1079454, ZF1091448, and ZF1125579.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading PA 19605
610-378-0131
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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