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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity Fusion Oxygenator w/ Arterial Filter, cardiotomy/Venous Reservoir, perfusion tubing packs

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  Class 2 Device Recall Affinity Fusion Oxygenator w/ Arterial Filter, cardiotomy/Venous Reservoir, perfusion tubing packs see related information
Date Initiated by Firm November 16, 2016
Date Posted December 20, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-0826-2017
Recall Event ID 75795
510(K)Number K142784  K132972  K924529  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Affinity Fusion" Oxygenator with Integrated Arterial Filter,
Affinity Fusion cardiotomy/Venous Reservoir,
Perfusion Tubing Packs

The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Code Information Product UPN/GTIN Lot Number Product Number 00643169650749 212028376 HY8N22R8 00643169802421 211984809 BB9D23R3 00643169707801 211991294 BB1D41R27 00643169871908 212073806 HY8B75R12 00643169621473 211950617 BB8U95R1 00643169860322 211865249 BB8E47R15 00643169865365 211975385 BB9D32R2 00643169860322 211991184 BB8E47R15 00643169717336 211991250 BB8Q09R2 00643169792852 211991385 BB9G59R5 00643169740020 211991295 HY8C67R10 00643169649101 211991248 BB7H73R14 00643169868120 212028234 BB8G43R3 00643169860322 212028305 BB8E47R15 00643169873032 212034498 HY9L88R2 00643169534629 212109150 BB7Z44R6 00643169591738 211846477 BB1A19R44 00643169786790 211991196 BB8X02R7 00643169639058 211846421 BB8N94R4 00643169649767 211991286 HY8J73R6 00643169869783 211991482 BB9E16R4 00643169861534 211914227 SSHY9M26R 00643169869516 211974259 BB9L66R 00643169872127 212020797 BB9L72R1 00643169736283 212028295 BB8S37R11 00643169776807 212028317 BB7X32R12 00643169546431 212028362 BB8C09R4 00643169786042 212028304 BB8Y15R1 00643169471597 212028389 BB4W65R13 00643169793699 212073805 BB8C33R6 00643169792036 211846376 BB8N34R5 00643169631649 212021402 BB8T05R1 00643169587106 212073934 HY0W84R28 00643169862920 211991252 HY8H59R17 00643169845121 212073924 BB4B15R13 00643169648111 211885327 BB8A57R11 00643169741720 211804528 BB3M00R29 00643169700284 211807907 HY1F66R18 00643169766839 211957793 BB8D44R4 00643169518131 211957865 HY8B26R4 00643169463929 211885289 BB5Z97R14 00643169714229 211991298 BB7U21R17 00643169617971 211918715 BB4Z62R17 00643169648111 211991256 BB8A57R11 00643169463929 211991381 BB5Z97R14 00643169724457 211892942 BB9B43R2 00643169862036 211951238 BB9H96R 00643169552852 211991198 BB8L58R3 00643169430143 212028385 BB1S56R19 00643169467873 211957783 BB7J04R9 00643169860322 212028306 BB8E47R15 00643169711945 212028358 BB8T77R2 00643169661295 212028419 HY8M65R2 00643169869820 212046220 HY7G33R8 00643169842441 212073804 HY8R55R3 00643169839274 212073871 HY5V41R19 00643169652941 212073987 BB8D56R9 00643169572263 212074010 HY8L55R5 00643169645424 212074022 BB8M16R3 00643169583238 211991253 CB2V10R24 00643169876903 212100880 BB8U52R8 00643169354869 13182438 BB841 00643169354883 13182603 BB841 00643169354883 13182626 BB841 00643169354869 13182721 BB841 00643169354869 13182733 BB841 00643169354883 13182822 BB841 00643169354883 13182950 BB841 00643169354883 13182977 BB841 00643169354883 13182978 BB841 00643169354883 13182979 BB841 00643169354883 13183344 BB841 00643169354869 13183378 BB841 00643169178168 13183475 BB811 00643169855465 211985748 HY9D36R1 00643169506169 211991194 BB5347R11 00643169654815 211991284 HY7W91R13 00643169872134 212020413 HY9B79R6 00643169855465 212028288 HY9D36R1 00643169649767 211991287 HY8J73R6 00643169747852 212028463 BB8A70R7 00643169672093 212028315 BB8X22R 00643169731165 212074008 BB8P98R2 00643169842823 212073900 HY5U30R10 00643169692145 212073983 HY7X48R10 00643169354883 13183553 BB841 00643169354883 13183609 BB841 00643169354883 13183727 BB841 00643169354869 13183944 BB841 00643169354883 13183963 BB841 00643169354883 13184174 BB841 00643169354883 13184206 BB841 00643169354883 13184587 BB841 00643169354883 13184871 BB841 00643169354883 13184872 BB841 00643169354883 13184873 BB841 00643169354883 13184952 BB841 00643169354883 13185297 BB841 00643169354883 13185542 BB841 00643169354883 13185788 BB841 00643169354883 13185992 BB841 00643169354883 13186074 BB841 00643169354883 13186127 BB841 00643169178175 13186543 BB811 
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
NE Mailstop LS245
Minneapolis MN 55432-5603
For Additional Information Contact Medtronic Representative
800-633-8766
Manufacturer Reason
for Recall		 Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
FDA Determined
Cause 2		 Process control
Action The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated November 2016 to its Consignees on 11/16/2016. The letter was addressed to Risk Manager or Healthcare Professional. The letter described the problem and the product involved in the recall and actions to be taken. The consignees were instructed to quarantine all unused affected product in your inventory, return the affected product (contact Medtronic Customer Service at 800-848-9300 to initiate a product return) and complete & return the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic.com. For questions contact your Medtronic Representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.
Quantity in Commerce 5609 (663 US; 4946 OUS)
Distribution Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.
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 = DTZ and Original Applicant = AVECOR CARDIOVASCULAR, INC.
510(K)s with Product Code = DTZ and Original Applicant = Medtronic, Inc
510(K)s with Product Code = DTZ and Original Applicant = MEDTRONIC, INC.
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