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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis ENDOVASCULAR Aviator

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  Class 2 Device Recall Cordis ENDOVASCULAR Aviator see related information
Date Initiated by Firm September 26, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0566-04
Recall Event ID 27450
510(K)Number K013851  
Product Classification Stent, Coronary - Product Code MAF
Product The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF Cat. No. Lot No., Use By Manufactured for: Cordis Europa N.V. 9301 LJRoden The Netherlands Method of Sterilization ETO Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure
Code Information New Lots with October 2003 or newer dating embedded in lot number (''1003'' MMYY in the second to fifth digit of Lot Number) and any older ones with a Green Dot indicating that they passed Cordis Inspection ARE NOT COVERED. The following previsouly uninspected lots were covered under the recall:  AVIATOR ITEM_NO LOT_NO 4224015S R0103043 4224015S R0202421 4224015S R0403032 4224015S R0603169 4224015S R0902952 4224015S R1102231 4224015S S0602108 4224015X R0303535 4224015X R0402115 4224015X R0603722 4224015X R0902953 4224015X R1002434 4224015X S0502104 4224020S R0102364 4224020S R0102920 4224020S R0103968 4224020S R0202151 4224020S R0202862 4224020S R0203105 4224020S R0203499 4224020S R0302900 4224020S R0502712 4224020S R0503318 4224020S R0602462 4224020S R0702480 4224020S R0802055 4224020S R0802263 4224020S R0802850 4224020S R0802863 4224020S R1002174 4224020S S0102054 4224020S S0102686 4224020S S0202251 4224020S S0602109 4224020S S1002019 4224020S S1002209 4224020X R0103044 4224020X R0103196 4224020X R0103714 4224020X R0103969 4224020X R0202004 4224020X R0202206 4224020X R0203106 4224020X R0302095 4224020X R0303719 4224020X R0603339 4224020X R0702481 4224020X R0702652 4224020X R0702915 4224020X R0802056 4224020X R0802269 4224020X R0902477 4224020X R1002935 4224020X R1102003 4224020X R1102019 4224020X S0102050 4224020X S0602110 4224020X S1002020 4224030S R0202207 4224030S S0102051 4224030X R0202209 4224030X R0303023 4224030X R0603480 4224030X R0703380 4224030X R0802270 4224030X R1002567 4224030X R1002681 4224030X S0102052 4224030X S0303012 4224040S R0202005 4224040S R0902705 4224040S S0202252 4224040X R0202210 4224040X R0203503 4224040X R0502606 4224040X R0603723 4224040X R0902562 4224040X R1202527 4224515S R0102923 4224515S R0303021 4224515S R0702656 4224515S R1002682 4224515X R0202422 4224515X R0303534 4224515X R0502832 4224520S R0302096 4224520S R0702482 4224520S S0302254 4224520X R0202423 4224520X R0202863 4224520X R0402641 4224520X R0502377 4224530X R0102922 4224530X R0302596 4224540X R0402885 4224540X S0602136 4225015S R0103045 4225015S R0103398 4225015S R0103971 4225015S R0202697 4225015S R0302599 4225015S R0403333 4225015S R0802864 4225015S S0502035 4225015S S0802199 4225015X R0103474 4225015X R0302097 4225015X R0303202 4225015X R0703132 4225015X R0902478 4225015X R1102232 4225015X S0402079 4225015X S0502134 4225020S R0102365 4225020S R0102366 4225020S R0102663 4225020S R0102703 4225020S R0103046 4225020S R0103715 4225020S R0202152 4225020S R0202698 4225020S R0202864 4225020S R0203107 4225020S R0302328 4225020S R0503679 4225020S R0702978 4225020S R0802271 4225020S R0802851 4225020S R0802865 4225020S S0102001 4225020S S0102415 4225020S S0802200 4225020X R0103475 4225020X R0103717 4225020X R0103970 4225020X R0202446 4225020X R0203108 4225020X R0203505 4225020X R0402642 4225020X R0403309 4225020X R0502092 4225020X R0503943 4225020X R0602336 4225020X R0702688 4225020X R0702916 4225020X R0702977 4225020X R0802272 4225020X R0802852 4225020X R0803122 4225020X R1002175 4225020X S0202007 4225020X S0402218 4225020X S0502383 4225020X S0802201 4225030S R0202565 4225030S S0502102 4225030X R0202566 4225030X S0202048 4225030X S0502103 4225040S R0302967 4225040S S0502135 4225040X R0103399 4225040X R0202699 4225040X R0403334 4225040X R0502378 4225040X R1002713 4225040X S0402219 4225515S R0202700 4225515S R0503714 4225515S S0802202 4225515X R0202788 4225515X R0303022 4225515X R0702689 4225515X R0802273 4225515X R1102020 4225520S R0202766 4225520S R0302647 4225520S R0602805 4225520X R0202767 4225520X R0302648 4225520X R0403033 4225520X R0602339 4225520X R0602812 4225520X S0502036 4225520X S0602137 4225530X R0402680 4225540X R0402116 4225540X R0403826 4226015S R0202768 4226015S R0203748 4226015S R0403620 4226015S R0502500 4226015S R0603490 4226015S R0702508 4226015S R1102583 4226015S S0802203 4226015X R0302649 4226015X R0602863 4226015X R0603487 4226015X R0902216 4226015X R1102230 4226015X S0202253 4226015X S1002212 4226020S R0102367 4226020S R0102665 4226020S R0102704 4226020S R0202003 4226020S R0202153 4226020S R0702510 4226020S R0702976 4226020S R0802853 4226020S R0902707 4226020S S0102149 4226020S S0102171 4226020S S0102262 4226020S S0302289 4226020S S0802180 4226020X R0103718 4226020X R0202785 4226020X R0203110 4226020X R0402117 4226020X R0502093 4226020X R0503154 4226020X R0602006 4226020X R0603725 4226020X R0702511 4226020X R0702690 4226020X R0702917 4226020X R0702975 4226020X R0703642 4226020X R0802274 4226020X R0802854 4226020X S0402220 4226020X S0802204 4226030S R0202786 4226030S S0602139 4226030X R0202787 4226030X R0302650 4226030X R0702700 4226030X R0702937 4226040S S0302319 4226040X R0103476 4226040X R0403827 4226040X R1102486 4226040X S0602111 4226515S R0402170 4226515S R0503379 4226515S R1002435 4226515X R0402171 4226515X R0503715 4226515X R0702512 4226515X R0802301 4226515X R0802855 4226520S R0402172 4226520X R0303203 4226520X R0402682 4226520X R0602007 4226520X R0702697 4226520X R1102487 4226530X R0402179 4226540X R0402174 4227015S R0402734 4227015S R0403621 4227015S R0502094 4227015S R0502501 4227015X R0203747 4227015X R0802304 4227015X S0602112 4227020S R0202154 4227020S R0402175 4227020S R0502548 4227020S R0602241 4227020S R0602595 4227020S S0102151 4227020X R0402176 4227020X R0402735 4227020X R0502095 4227020X R0602008 4227020X R0702699 4227020X R0702934 4227020X R0703246 4227020X R0802134 4227020X R0802302 4227020X R0802866 4227030S S0402222 4227030X R0402177 4227030X R0402760 4227040S R0402178 4227040S R0502096 4227040X R0503680 4227040X R0702936 4227040X R0802303 4227040X S0602113                                                             
Recalling Firm/
Cordis Corporation
14201 N.W. 60th Ave
Miami Lakes FL 33014
For Additional Information Contact Hal Delgado
Manufacturer Reason
for Recall
A packaging defect may compromise the device's sterility barrier.
FDA Determined
Cause 2
Action The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 2004.
Quantity in Commerce Total for both devices of 39,726
Distribution Product was distributed nationwide to 1035 domestic hospital accounts no international, government or military accounts.
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.