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U.S. Department of Health and Human Services

Class 2 Device Recall ArrowFlex(R) Percutaneous Sheath Introducer Kit

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  Class 2 Device Recall ArrowFlex(R) Percutaneous Sheath Introducer Kit see related information
Date Initiated by Firm April 11, 2018
Create Date May 30, 2018
Recall Status1 Terminated 3 on May 15, 2020
Recall Number Z-1975-2018
Recall Event ID 79890
510(K)Number K940079  
Product Classification Introducer, catheter - Product Code DYB
Product Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters
; Product Codes: ASK-09903-UM








Code Information Lot Numbers:  13F17A0258 13F17D0075 13F17G0275 13F17L0615              
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
Manufacturer Reason
for Recall
Product sterility may be compromised due to unsealed packaging.
FDA Determined
Cause 2
Under Investigation by firm
Action On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.
Quantity in Commerce 416,055 total products
Distribution US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
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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