Datascope Intra-Aortic Ballon Catheters recall: Endotoxin
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…
Why was Datascope Intra-Aortic Ballon Catheters recalled?
Potential Endotoxin Contamination
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lot Number: 3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932
- 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…
- Recalling firm
- Datascope Corporation
- Quantity
- 69278 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.
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)