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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Transradial Artery Access products

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 Class 2 Recall
Arrow Transradial Artery Access products
see related information
Date Posted December 09, 2013
Recall Status1 Open
Recall Number Z-0468-2014
Recall Event ID 66586
Premarket Notification
510(K) Numbers
K112554  K780532 
Product Classification Introducer, Catheter - Product Code DYB
Product Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Code Information Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06 AA-15511-S RF0021262 2015-02 AA-15611-S RF1069978 2016-06 AA-15611-S RF0021263 2015-03 AA-15611-S RF1070556 2016-07 AA-15511-S RF0022395 2015-03, AA-15611-S RF1070730 2016-07, AA-15611-S RF0022652 2015-03, AA-15511-S RF1070880 2016-07, AA-15511-S RF0033719 2015-03, AA-15611-S RF1071062 2016-07, AA-15511-S RF0046459 2015-04, AA-15611-S RF1071206 2016-08, AA-15611-S RF0046461 2015-04, AA-15511-S RF1071354 2016-07, AA-15611-S RF0048269 2015-05, AA-15611-S RF1071757 2016-08, AA-15511-S RF0059652 2015-06, AA-15511-S RF1071798 2016-08, AA-15511-S RF0062416 2015-06, AA-15611-S RF1082042 2016-08, AA-15611-S RF0062419 2015-06, AA-15611-S RF1082374 2016-08, AA-15611-S RF0087575 2015-08, AA-15611-S RF1082709 2016-08, AA-15511-S RF0087577 2015-08, AA-15611-S RF1082956 2016-08, AA-15611-S RF0087845 2015-08, AA-15511-S RF1082959 2016-08, AA-15511-S RF0088503 2015-08, AA-15511-S RF1083632 2016-09, AA-15611-S RF0089041 2015-08, AA-10407-1 RF1093923 2013-09, AA-15511-S RF0091088 2015-09, AA-10507-1 RF1093924 2013-09, AA-15611-S RF0092014 2015-09, AA-10511-1 RF1093925 2013-09, AA-15511-S RF0092144 2015-09, AA-15511-S RF1093936 2016-09, AA-15511-S RF0104465 2015-10, AA-15611-S RF1093937 2016-09, AA-15611-S RF0104466 2015-10, AA-15611-S RF1094515 2016-10, AA-15611-S RF0115587 2015-11, AA-15511-S RF1094910 2016-10, AA-15511-S RF0115903 2015-11, AA-15611-S RF1105690 2016-10, AA-15611-S RF0117454 2015-12, AA-15611-S RF1105980 2016-10, AA-15511-S RF0117682 2015-12, AA-15511-S RF1105983 2016-10, AA-15611-S RF0129193 2016-01, AA-15511-S RF1106517 2016-11, AA-15611-S RF1010343 2016-01, AA-15611-S RF1117682 2016-11, AA-15611-S RF1011171 2016-01, AA-15611-S RF1128383 2016-12, AA-15511-S RF1011172 2016-01, AA-15511-S RF2010359 2017-01, AA-15511-S RF1019756 2016-01, AA-15611-S RF2010467 2017-02, AA-15511-S RF1022056 2016-02, AA-15511-S RF2010675 2017-02, AA-15611-S RF1023132 2016-03, AA-15611-S RF2010868 2017-02, AA-15611-S RF1033969 2016-03, AA-15611-S RF2019197 2017-01, AA-15611-S RF1034279 2016-03, AA-15511-S RF2019230 2017-01, AA-15611-S RF1035009 2016-04, AA-15611-S RF2019759 2017-01, AA-15511-S RF1035112 2016-04, AA-15511-S RF2021565 2017-03, AA-15611-S RF1045491 2016-04, AA-15611-S RF2021612 2017-03, AA-15511-S RF1045951 2016-04, AA-15611-S RF2022115 2017-03, AA-15611-S RF1046643 2016-05, AA-15611-S RF2022510 2017-03, AA-15611-S RF1046962 2016-05, AA-15611-S RF2033301 2017-03, AA-15511-S RF1057481 2016-05, AA-15511-S RF2033341 2017-03, AA-15511-S RF1060013 2016-07, AA-15611-S RF2033811 2017-03, AA-15611-S RF1060349 2016-07, AA-15611-S RF2044703 2017-04, AA-15611-S RF1068720 2016-06, AA-15511-S RF2044756 2017-04, AA-15511-S RF1069507 2016-06, AA-15611-S RF2045176 2017-04, AA-15511-S RF2045508 2017-05, AA-10607-1 RF2107371 2014-10, AA-15611-S RF2045513 2017-04, AA-15511-3 RF2107374 2014-10, AA-15611-S RF2046241 2017-05, AA-10507-1 RF2107659 2014-10, AA-15611-S RF2056688 2017-05, AA-10507-1 RF2108238 2014-10, AA-10407-1 RF2056874 2014-05, AA-15511-3 RF2108239 2014-10, AA-10407-1 RF2057003 2014-05, AA-15511-S RF2108240 2017-10, AA-15611-S RF2057702 2017-05, AA-15611-3 RF2108243 2014-10, AA-15611-S RF2058443 2017-06, AA-10511-1 RF2108519 2014-10, AA-15611-S RF2058727 2017-06, AA-10524-1 RF2108830 2014-11, AA-15611-S RF2060013 2017-06, AA-10611-1 RF2109094 2014-11, AA-15611-S RF2060748 2017-07, AA-10507-1 RF2110742 2015-01, AA-15611-S RF2069110 2017-06, AA-10607-1 RF2111224 2015-01, AA-15511-S RF2071172 2017-07, AA-15511-S RF2119659 2017-11, AA-15611-S RF2071228 2017-07, AA-10611-1 RF3013490 2015-01, AA-10611-1 RF2071405 2014-07, AA-15511-S RF8095418 2013-09, AA-10624-1 RF2071406 2014-07, AA-15611-S RF8095420 2013-09, AA-10511-1 RF2071407 2014-07, AA-15511-S RF8095817 2013-09, AA-10507-1 RF2071408 2014-07, AA-15611-S RF8096588 2013-09, AA-10607-1 RF2071409 2014-07, AA-15511-S RF8097142 2013-10, AA-10507-1 RF2071428 2014-07, AA-15611-S RF8097143 2013-10, AA-15511-S RF2071836 2017-07, AA-15611-S RF8108474 2013-10, AA-15511-S RF2072114 2017-08, AA-15511-S RF8109405 2013-10, AA-15611-S RF2072265 2017-07, AA-15611-S RF8110519 2013-11, AA-10407-1 RF2072322 2014-08, AA-15611-S RF8111258 2013-11, AA-10511-1 RF2072700 2014-08, AA-15511-S RF8119837 2013-11, AA-10507-1 RF2082733 2014-08, AA-15611-S RF8119838 2013-11, AA-10607-1 RF2082876 2014-08, AA-15511-S RF8122732 2013-12, AA-10507-1 RF2083221 2014-08, AA-15611-S RF8122734 2013-12, AA-15511-S RF2083300 2017-08, AA-15511-S RF9014645 2014-01, AA-10624-1 RF2083454 2014-08, AA-15611-S RF9014646 2014-01, AA-10511-1 RF2083574 2014-08, AA-15511-S RF9027936 2014-02, AA-10611-1 RF2083576 2014-08, AA-15611-S RF9027938 2014-02, AA-10624-1 RF2083577 2014-08, AA-15511-S RF9030868 2014-04, AA-10507-1 RF2083578 2014-08, AA-15611-S RF9030870 2014-04, AA-15611-S RF2083790 2017-08, AA-15511-S RF9043881 2014-05, AA-10607-1 RF2083917 2014-08, AA-15611-S RF9056723 2014-06, AA-15611-S RF2084674 2017-09, AA-15511-S RF9057834 2014-06, AA-10611-1 RF2084732 2014-09, AA-15611-S RF9069105 2014-07, AA-15511-S RF2084734 2017-09, AA-15611-S RF9070830 2014-08, AA-10511-1 RF2095165 2014-09, AA-15511-S RF9073033 2014-08, AA-10611-1 RF2096244 2014-09, AA-15611-S RF9085114 2014-08, AA-10611-1 RF2096785 2014-10, AA-15511-S RF9085142 2014-08, AA-15611-S RF9085720 2014-09, AA-15611-S RF9086531 2014-09, AA-15611-S RF9100255 2014-10, AA-15511-S RF9101704 2014-11, AA-15511-S RF9109533 2014-10, AA-15611-S RF9112368 2014-11, AA-15611-S RF9114142 2014-11, AA-15511-S RF9114143 2014-11, AA-15611-S RF9127372 2015-01, AA-15511-S RF9127374 2015-01, AA-15611-S RV0018374 2015-01, AA-15611-S RV0018375 2015-01, AA-15611-S RV0018376 2015-01, AA-15611-S RV0018927 2015-01, AA-10507-1 RV2069822 2014-06, AA-10607-1 RV2069823 2014-06, AA-10511-1 RV2069824 2014-06, AA-10611-1 RV2069826 2014-06, AA-10624-1 RV2069827 2014-06, AA-15511-3 RV2095275 2014-09, AA-15611-3 RV2095276 2014-09, AA-15611-3 RV2096130 2014-09, AA-15511-3 RV2096154 2014-09, AA-10411-1 RV2096427 2014-09, AA-10524-1 RV2096435 2014-09.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-800-343-2935. For questions regarding this recall call 610-378-0131.
Quantity in Commerce 294430
Distribution Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.
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 = DYB and Original Applicant = ARROW INTL., INC.
510(K)s with Product Code = DYB and Original Applicant = Teleflex Medical, Inc.
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