Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - 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: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589
- 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)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
Kit Lot Number: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2846-2020
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