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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow International, Inc.

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  Class 2 Device Recall Arrow International, Inc. see related information
Date Initiated by Firm February 05, 2015
Date Posted March 02, 2015
Recall Status1 Terminated 3 on October 26, 2016
Recall Number Z-1233-2015
Recall Event ID 70436
510(K)Number K021462  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr
Product Code: IAB-05840-LWS
The Arrow IAB is utilized for intra-aortic balloon counter-pulsation 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 Lot Number: 18F14M0001
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		 Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
FDA Determined
Cause 2		 Labeling mix-ups
Action Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in Commerce 165 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Belgium
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 = DSP and Original Applicant = ARROW INTL., INC.
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