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U.S. Department of Health and Human Services

Class 2 Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

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  Class 2 Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port see related information
Date Initiated by Firm March 25, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on January 29, 2014
Recall Number Z-2048-2011
Recall Event ID 58331
510(K)Number K780532  
Product Classification Introducer, catheter - Product Code DYB
Product Percutaneous Sheath Introducer Kit

Intended usage: Permits venous access and catheter introduction to the central circulation system
Code Information Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Tracy Larish
610-378-0131
Manufacturer Reason
for Recall		 Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.
FDA Determined
Cause 2		 Other
Action The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.
Quantity in Commerce 840
Distribution Nationwide distribution: USA including states of: PA and NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ARROW INTL., INC.
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