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 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: 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
- 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 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2844-2020
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