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U.S. Department of Health and Human Services

Class 1 Device Recall FiberOptix IAB

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  Class 1 Device Recall FiberOptix IAB see related information
Date Initiated by Firm October 11, 2010
Date Posted December 23, 2010
Recall Status1 Terminated 3 on February 05, 2015
Recall Number Z-0792-2011
Recall Event ID 56965
510(K)Number K000729  K021462  
Product Classification Intra-Aortic Balloon and Control System - Product Code DSP
Product FiberOptix IAB Sheath, Ultra 8 Fr, 30cc.
Model: IAB-05830-LWS
Code Information Lot Numbers: KF0097980 KF0097981 KF0097982 KF0098037 KF0098079 KF0108149 KF0108194 KF0108242 KF0108294 MF0011388 MF0021613 MF0021614 MF0021615 MF0021616 MF0031841 MF0031842 MF0032167 MF0042396 MF0042783 MF0042784 MF0042785 MF0053022 MF0063352 MF0073779 MF0073902 MF0074070 MF7065674 MF7128561 MF8092999 MF8103156 MF8113922 MF8114009 MF8124160 MF8124308 MF8124409 MF9025252 MF9025253 MF9025254 MF9025255 MF9025320 MF9025322 MF9035383 MF9035385 MF9035611 MF9035612 MF9035835 MF9035954 MF9056741 MF9056846 MF9057067 MF9067348 MF9067349 MF9067737 MF9077887 MF9077970 MF9077972 MF9078195 MF9078196 MF9078197 MF9078198 MF9078200 MF9078344 MF9078345 MF9078346 MF9078347 MF9088679 MF9088680 MF9099229 MF9099230 MF9099231 MF9099232 MF9099233 MF9099310 MF9099353 MF9100006 MF9100007 MF9109757 MF9109758 MF9110055 MF9110192 MF9110303 MF9110304 MF9110305 MS9056709 MS9056810 MS9056811 MS9109705 MS9109708  
Recalling Firm/
Manufacturer		 Arrow International, Inc., Division of Teleflex Medical Inc.
9 Plymouth St
Everett MA 02149-1814
For Additional Information Contact SAME
617-389-6400
Manufacturer Reason
for Recall		 SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
FDA Determined
Cause 2		 Device Design
Action Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
Quantity in Commerce 12, 261 units
Distribution Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
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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