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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Internationa IABP

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  Class 2 Device Recall Arrow Internationa IABP see related information
Date Initiated by Firm November 27, 2012
Date Posted April 06, 2013
Recall Status1 Terminated 3 on June 02, 2015
Recall Number Z-1065-2013
Recall Event ID 64527
510(K)Number K000729  K021462  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc;
Product Number: IAB-05840-LWS.

The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Code Information Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Jennifer Thompson
610-378-0131 Ext. 3474
Manufacturer Reason
for Recall		 Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
FDA Determined
Cause 2		 Process control
Action Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.
Quantity in Commerce 637 units
Distribution Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
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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