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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DSP
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