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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-2834-2020
Recall Event ID 85823
510(K)Number K063525  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09.
Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Code Information Kit Lot Number:  3000045657 3000047164 3000048708 3000049477 3000050927 3000051753 3000051754 3000052790 3000053815 3000053816 3000056436 3000058893 3000059906 3000063263 3000064521 3000065233 3000066677 3000067689 3000071413 3000072399 3000074269 3000075922 3000077813 3000080874 3000081078 3000083096 3000084472 3000084787 3000086850 3000087366 3000088618 3000089991 3000090768 3000094337 3000097300 3000098247 3000099929 3000102977 3000106755 3000110208 3000111136 3000058894 3000070665 3000073189 3000077203 3000080875 3000084690 3000086792 3000089348 3000094338 3000103213 3000110209 3000045656 3000047710 3000048709 3000049478 3000050926 3000051752 3000052791 3000053817 3000056437 3000059907 3000061290 3000061291 3000064520 3000065234 3000065987 3000066678 3000067690 3000068924 3000069876 3000071218 3000071977 3000071978 3000073188 3000074270 3000076924 3000077812 3000080877 3000081077 3000083095 3000086851 3000087367 3000088617 3000090767 3000092537 3000094336 3000097301 3000098248 3000099928 3000102978 3000106754 3000110207 3000111137 3000046410 3000083097 3000111135 3000103214 3000110210 3000111192 
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 13335 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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