Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Kit Lot Number: 3000047804 3000053322 3000053323 3000060107 3000060108 3000062255 3000067698 3000069727 3000071976 3000073186 3000073680 3000073681 3000074885 3000076710 3000076711 3000077752 3000077753 3000079103 3000079104 3000080873 3000080872 3000081671 3000084267 3000084966 3000084965 3000086799 3000088548 3000088371 3000090599 3000090600 3000090601 3000090602 3000090603 3000092664 3000092663 3000092665 3000096263 3000095467 3000096264 3000096265 3000096266 3000098176 3000098177 3000102408 3000102409 3000103469 3000104520 3000104615 3000106012 3000107758 3000107759 3000110626 3000113155 3000112276 3000113156
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Datascope Corporation
- Reason for Recall:
- Potential Endotoxin Contamination
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
Kit Lot Number: 3000047804 3000053322 3000053323 3000060107 3000060108 3000062255 3000067698 3000069727 3000071976 3000073186 3000073680 3000073681 3000074885 3000076710 3000076711 3000077752 3000077753 3000079103 3000079104 3000080873 3000080872 3000081671 3000084267 3000084966 3000084965 3000086799 3000088548 3000088371 3000090599 3000090600 3000090601 3000090602 3000090603 3000092664 3000092663 3000092665 3000096263 3000095467 3000096264 3000096265 3000096266 3000098176 3000098177 3000102408 3000102409 3000103469 3000104520 3000104615 3000106012 3000107758 3000107759 3000110626 3000113155 3000112276 3000113156
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2843-2020
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