Class 2 Device Recall Datascope

• Date Initiated by Firm: July 27, 2020
• Date Posted: August 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2832-2020
• Recall Event ID: 85823
• 510(K)Number: K120868
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10; -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
• Code Information: Kit Lot Number: 3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156
• 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: 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: 16104 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