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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-2833-2020
Recall Event ID 85823
510(K)Number K120868  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08

Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Code Information Kit Lot Number:  3000046414 3000047431 3000048243 3000049080 3000049569 3000050495 3000051154 3000051751 3000053311 3000054591 3000054592 3000056356 3000056629 3000058277 3000060542 3000064249 3000066800 3000065563 3000067963 3000070668 3000071291 3000071979 3000073516 3000074146 3000075999 3000078921 3000080138 3000080137 3000081624 3000082197 3000082848 3000083430 3000084785 3000086995 3000087888 3000089898 3000091753 3000092239 3000092240 3000094450 3000094451 3000095604 3000096970 3000097957 3000100722 3000105063 3000102628 3000105064 3000107101 3000108962 3000109818 3000112782 3000046415 3000047430 3000048245 3000049085 3000049570 3000051153 3000051881 3000053310 3000054729 3000056538 3000059168 3000059618 3000060730 3000060451 3000064248 3000066798 3000065636 3000066799 3000067964 3000070669 3000071292 3000071980 3000073517 3000074144 3000074145 3000076000 3000078922 3000080140 3000082847 3000083431 3000083989 3000084730 3000087112 3000088376 3000089899 3000091754 3000092134 3000094449 3000095692 3000096971 3000097952 3000097953 3000100721 3000102697 3000105062 3000107100 3000109817 3000111681 3000113153 3000048244 3000049567 3000050496 3000051155 3000053312 3000054730 3000059169 3000060545 3000060543 3000066063 3000064842 3000064843 3000066801 3000066802 3000066803 3000076001 3000080543 3000080544 3000081621 3000082189 3000084786 3000086996 3000091755 3000092238 3000097956 3000102698 3000105060 3000106965 3000112155 3000112156 3000046416 3000047435 3000049568 3000056539 3000059619 3000064250 3000066804 3000066805 3000067857 3000070670 3000073518 3000074162 3000078923 3000080139 3000084731 3000097954 3000102699 3000108432 3000112154 3000103022 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 31529 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., CARDIAC ASSIST DIVISION
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