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

Recall

57218

Class 2

Z-0898-2011

2010-11-09

2011-01-12

Terminated

United States

2012-09-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95621

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.

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.