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U.S. Department of Health and Human Services

Class 2 Device Recall Datascope

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  Class 2 Device Recall Datascope see related information
Date Initiated by Firm July 27, 2020
Date Posted August 21, 2020
Recall Status1 Open3, Classified
Recall Number Z-2840-2020
Recall Event ID 85823
510(K)Number K041281  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB
Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07,
0684-00-0480-08, 0684-00-0480-10
Code Information Kit Lot Number:  3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 3000054067 3000054914 3000057090 3000058631 3000059460 3000060261 3000060731 3000060848 3000062743 3000064057 3000071409 3000065401 3000065942 3000066768 3000067500 3000068688 3000068689 3000070070 3000072315 3000072885 3000083860 3000075682 3000076775 3000079570 3000080053 3000077520 3000077941 3000078503 3000078600 3000078656 3000079242 3000080764 3000081888 3000082186 3000082885 3000083861 3000084565 3000084851 3000085193 3000087974 3000088594 3000088639 3000089730 3000090853 3000091126 3000091327 3000092503 3000093663 3000095290 3000095946 3000096738 3000097654 3000099417 3000100344 3000101784 3000103915 3000105898 3000106317 3000109026 3000111350 3000111973 3000048959 3000047353 3000047706 3000048026 3000048961 3000048960 3000048962 3000050258 3000051647 3000052948 3000054290 3000054291 3000054967 3000056074 3000057384 3000058896 3000058897 3000060262 3000060733 3000063082 3000063083 3000064046 3000066141 3000066142 3000066284 3000067688 3000069656 3000069657 3000070408 3000070664 3000071058 3000071414 3000073065 3000073403 3000075684 3000079569 3000080103 3000077273 3000077519 3000078683 3000080104 3000080443 3000080782 3000082659 3000083600 3000085381 3000086267 3000087315 3000089459 3000090849 3000092396 3000093113 3000094005 3000095038 3000095945 3000098249 3000100378 3000102536 3000103919 3000106447 3000109023 3000110738 3000115116 3000116665 3000047198 3000047708 3000049208 3000049723 3000051122 3000052154 3000052155 3000053152 3000053792 3000054880 3000056191 3000056936 3000057345 3000058847 3000060260 3000060587 3000063258 3000064097 3000065030 3000065853 3000065943 3000066282 3000067497 3000068770 3000069317 3000070409 3000070410 3000071410 3000072886 3000072916 3000075681 3000076776 3000075131 3000079466 3000080054 3000077522 3000077523 3000077524 3000078051 3000078684 3000080537 3000080783 3000081157 3000083094 3000083092 3000083093 3000080538 3000084692 3000085501 3000085502 3000087316 3000087317 3000087975 3000088620 3000089731 3000090848 3000091184 3000091328 3000093664 3000095289 3000097650 3000099419 3000098615 3000099420 3000100266 3000101785 3000103920 3000105895 3000106449 3000106450 3000109025 3000110414 3000111358 3000111359 3000116581 3000046737 3000047275 3000047637 3000048223 3000048400 3000049421 3000049722 3000050669 3000051151 3000051152 3000052046 3000053049 3000054337 3000054915 3000057067 3000057385 3000057386 3000058630 3000060734 3000062028 3000062697 3000065235 3000065854 3000066769 3000067531 3000067532 3000067533 3000067891 3000068434 3000068731 3000069377 3000070489 3000071411 3000072230 3000072884 3000073275 3000075683 3000075675 3000075963 3000077521 3000077940 3000078502 3000078601 3000079315 3000079829 3000078934 3000080098 3000080780 3000082187 3000085290 3000087124 3000087976 3000088621 3000090854 3000091039 3000091040 3000091477 3000093115 3000095291 3000095796 3000097651 3000097652 3000098613 3000099418 3000100066 3000100346 3000101786 3000106316 3000108557 3000109401 3000110454 3000110735 3000115917 3000097096 3000046499 3000047201 3000049313 3000054879 3000056192 3000058580 3000062803 3000065029 3000065852 3000066283 3000069316 3000070488 3000072248 3000076777 3000075132 3000079467 3000079941 3000078050 3000080781 3000085503 3000088490 3000089725 3000090855 3000093675 3000097057 3000100067 3000101787 3000105897 3000109024 3000066139 3000067810 3000071126 3000072259 3000083859 3000077205 3000079828 3000082126 3000080463 3000084652 3000085504 3000087161 3000100856 3000103052 3000103053 3000107166 3000107281 3000107909 3000110205 3000046814 3000047059 3000056260 3000061584 3000076778 3000081156 3000100000 3000101129 3000101130 3000094152 3000095152 3000096000 3000097653 3000103055 3000103916 3000105384 3000106448 3000109400 3000116582 3000047356 3000048230 3000049055 3000051378 3000054590 3000056355 3000056628 3000059148 3000060544 3000068926 3000068941 3000073404 3000074166 3000074890 3000076131 3000076402 3000078920 3000080420 3000081777 3000083598 3000085937 3000090852 3000089347 3000091872 3000094108 3000094935 3000096067 3000095318 3000096066 3000097959 3000100857 3000100582 3000102905 3000105061 3000107102 3000108963 3000111680 3000113152 3000068029 3000071836 3000074163 3000103039 3000106964 
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact SAME
973-244-6100
Manufacturer Reason
for Recall		 Potential Endotoxin Contamination
FDA Determined
Cause 2		 Process change control
Action Datascope/Getinge issued Urgent Medical Device Removal letter (customer specific) on 7/27/20, via FedEx with Signature Proof of Delivery. Letter states reason for recall, health risk and action to take: Records indicate that you received potentially affected IABs identifiable by the lot and serial numbers listed . Please complete the steps below: Monitor patients for pyrogens reaction/humoral immune response/ coagulation and complement cascades/ inflammation. Monitor and treat any signs of inflammation according to your facilitys protocols and clinical judgment. ¿ Please examine your inventory immediately, remove and quarantine any unexpired affected IAB following the steps below: Identify any unexpired IAB Kits referencing the part and lot numbers listed in Table 1. The Kit part and lot numbers can be found on the Outer Shelf Carton Using steps below, Identify any IAB Yfittings with serial numbers listed in Table 1. ¿ Remove tape on one side of the Shelf Carton. ¿ Hinge the box open, keeping the other side taped. ¿ Do not remove any items from the carton. Instead, Lift the Accessories up and locate the YFitting through the clear Mylar overwrap. ¿ Read the serial number off the IAB YFitting ¿ If you find an IAB with a serial number listed in Table 1, immediately place the entire Kit in quarantine for return and replacement or credit. ¿ If the affected serial number is not found, close the carton and reseal. Cut out and affix one of the enclosed adhesive labels to designate the kit has been checked for affected recall Serial Numbers and may be placed back in stock. 40 peeloff labels have been provided. Color copies may be made and affixed with tape if more than 40 are needed. ¿ If you have unexpired affected product to return, please contact Getinge Customer Service at 888 9GETUSA (8889438872) (option 2) between the hours of 9 AM and 6 PM Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. Pack th
Quantity in Commerce 116652 Kits WW
Distribution Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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