Datascope Intra-Aortic Ballon Catheters recall: Endotoxin
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use…
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: 3000053317 3000056694 3000057318 3000057970 3000062073 3000062639 3000062640 3000068106 3000071287 3000072717 3000064723 3000072718 3000072719 3000074886 3000087744 3000090528 3000076632 3000078856 3000080307 3000083331 3000084962 3000092774 3000092775 3000095473 3000096376 3000096606 3000096379 3000098751 3000104521 3000115011
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use…
- Recalling firm
- Datascope Corporation
- Quantity
- 3055 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)