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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-2845-2020
Recall Event ID 85823
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Code Information Kit Lot Number:  3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 3000057317 3000057967 3000066213 3000066214 3000068109 3000068110 3000068111 3000069731 3000071412 3000072401 3000072402 3000073682 3000073816 3000073817 3000074887 3000083328 3000083329 3000087746 3000076462 3000078855 3000079319 3000079320 3000083326 3000080308 3000083327 3000087747 3000090530 3000090531 3000092773 3000096367 3000096368 3000095471 3000096369 3000096370 3000096371 3000096372 3000096373 3000096374 3000098749 3000098750 3000103503 3000103504 3000103505 3000103506 3000110580 3000110581 3000110582 3000110583 3000110584 3000113008 3000113009 3000113148 3000115015 
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 6111 Kits
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.
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