Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -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: 3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156
- 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 Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
Kit Lot Number: 3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2832-2020
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