Datascope Intra-Aortic Ballon Catheters recall: Endotoxin
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute…
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: 3000045568 3000047929 3000047928 3000047930 3000053321 3000060109 3000060110 3000067699 3000062192 3000067700 3000067701 3000069728 3000069729 3000069730 3000071288 3000073187 3000076242 3000077669 3000079105 3000079318 3000080309 3000080876 3000084268 3000084967 3000084960 3000084961 3000086800 3000088372 3000090597 3000090598 3000092668 3000092666 3000092667 3000092669 3000096268 3000095468 3000096267 3000096269 3000096270 3000096271 3000096587 3000098175 3000098747 3000098748 3000102410 3000102411 3000103470 3000104519 3000106011 3000107760 3000110622 3000110623 3000112744 3000113154
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute…
- Recalling firm
- Datascope Corporation
- Quantity
- 11555 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)