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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-2831-2020
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 7.5Fr 30cc IAB,
P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Code Information Kit Lot Number:  3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152 
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 1275 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., CARDIAC ASSIST DIVISION
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