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U.S. Department of Health and Human Services

Class 1 Device Recall Percutaneous Insertion Tray

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  Class 1 Device Recall Percutaneous Insertion Tray see related information
Date Initiated by Firm February 10, 2016
Create Date March 11, 2016
Recall Status1 Completed
Recall Number Z-1062-2016
Recall Event ID 73266
510(K)Number K000729  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Percutaneous Insertion Tray; Product Code: IAK-06845

The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Code Information Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028 
Recalling Firm/
Manufacturer
Arrow International, Inc., Division of Teleflex Medical Inc.
9 Plymouth St
Everett MA 02149-1814
For Additional Information Contact
617-389-6400
Manufacturer Reason
for Recall
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product 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 it to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 13,405 US and 33,735 OUS in total
Distribution Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
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.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.
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