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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 Recall
Arrow Internationa IABP
see related information
Date Posted April 06, 2013
Recall Status1 Open
Recall Number Z-1065-2013
Recall Event ID 64527
Premarket Notification
510(K) Numbers
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, Pennsylvania 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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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