Device product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Z-2836-2020
Product summary
- Event
- Event 85823
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29653 kits WW
- Official record key
device-enforcement:Z-2836-2020
Official wording
Reason: Potential Endotoxin Contamination
Code information: Kit Lot Number: 3000102215 3000102248 3000102249 3000103405 3000103406 3000105261 3000105262 3000106963 3000107331 3000107332 3000108589 3000108881 3000110520 3000111682 3000113810 3000046748 3000102329 3000103404
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential Endotoxin Contamination