Device product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Z-2837-2020
Product summary
- Event
- Event 85823
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69278 kits
- Official record key
device-enforcement:Z-2837-2020
Official wording
Reason: Potential Endotoxin Contamination
Code information: Kit Lot Number: 3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932
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