Recall Z-2839-2020
Datascope Corporation · initiated July 27, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Codes / lots: Kit Lot Number: 3000047635 3000048712 3000048711 3000049311 3000051296 3000052326 3000053634 3000054821 3000056194 3000057204 3000058417 3000059272 3000059273 3000061448 3000062934 3000065133 3000065724 3000066487 3000068135 3000069877 3000071129 3000071890 3000073519 3000074021 3000075917 3000076955 3000079930 3000077811 3000079055 3000079517 3000080673 3000082253 3000083197 3000084068 3000084852 3000084853 3000085756 3000086925 3000088673 3000089610 3000091320 3000091698 3000093895 3000096739 3000100472 3000101934 3000105734 3000106532 3000106533 3000109449 3000113519 3000116780 3000047354 3000047707 3000048027 3000048963 3000050259 3000051645 3000051646 3000052792 3000054317 3000054873 3000056073 3000057383 3000058898 3000058899 3000059609 3000061524 3000062026 3000063084 3000064055 3000066140 3000066513 3000066514 3000068859 3000070407 3000071128 3000071415 3000073402 3000074029 3000075865 3000077274 3000080105 3000077560 3000079568 3000080106 3000080444 3000080732 3000082660 3000083200 3000084477 3000085500 3000085845 3000086491 3000089458 3000090850 3000091740 3000093114 3000094658 3000095998 3000095999 3000098650 3000100381 3000102537 3000103918 3000105531 3000106633…
Reason for recall
Potential Endotoxin Contamination
FDA-determined cause: Process change control
Action taken
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
Details
- Recall number
- Z-2839-2020
- Initiated
- July 27, 2020
- Posted by FDA
- August 21, 2020
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 54816 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…
- Recalling firm
- Datascope Corporation, Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2831-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2832-2020 Class II | Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2833-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2834-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2835-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2836-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2837-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2838-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2840-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2841-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2842-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2843-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2844-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2845-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2846-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2847-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |