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U.S. Department of Health and Human Services

Class 2 Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter

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 Class 2 Recall
ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
see related information
Date Posted January 12, 2011
Recall Status1 Terminated on September 29, 2012
Recall Number Z-0898-2011
Recall Event ID 57218
Premarket Notification
510(K) Number
K862056 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation.
Code Information Lot/Serial Number: CF9065974.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Mrs. Tracey Larish
610-378-0131 Ext. 3835
Manufacturer Reason
for Recall
One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.
Quantity in Commerce 1150 units
Distribution International Distribution Only -- Argentina and Columbia.
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 = DQY and Original Applicant = ARROW INTL., INC.
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