Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - 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: 3000047635 3000048712 3000048711 3000049311 3000051296 3000052326 3000053634 3000054821 3000056194 3000057204 3000058417 3000059272 3000059273 3000061448 3000062934 3000065133 3000065724 3000066487 3000068135 3000069877 3000071129 3000071890 3000073519 3000074021 3000075917 3000076955 3000079930 3000077811 3000079055 3000079517 3000080673 3000082253 3000083197 3000084068 3000084852 3000084853 3000085756 3000086925 3000088673 3000089610 3000091320 3000091698 3000093895 3000096739 3000100472 3000101934 3000105734 3000106532 3000106533 3000109449 3000113519 3000116780 3000047354 3000047707 3000048027 3000048963 3000050259 3000051645 3000051646 3000052792 3000054317 3000054873 3000056073 3000057383 3000058898 3000058899 3000059609 3000061524 3000062026 3000063084 3000064055 3000066140 3000066513 3000066514 3000068859 3000070407 3000071128 3000071415 3000073402 3000074029 3000075865 3000077274 3000080105 3000077560 3000079568 3000080106 3000080444 3000080732 3000082660 3000083200 3000084477 3000085500 3000085845 3000086491 3000089458 3000090850 3000091740 3000093114 3000094658 3000095998 3000095999 3000098650 3000100381 3000102537 3000103918 3000105531 3000106633 3000109450 3000110736 3000113520 3000115115 3000048818 3000049422 3000049791 3000051295 3000053635 3000054874 3000057267 3000058418 3000058848 3000059458 3000061477 3000062027 3000065130 3000065722 3000066766 3000068923 3000070426 3000070663 3000071289 3000072588 3000072587 3000073520 3000074020 3000075914 3000076953 3000076954 3000079932 3000077810 3000079516 3000080539 3000082534 3000083198 3000084476 3000085814 3000086855 3000088103 3000089732 3000091321 3000091322 3000093116 3000094007 3000100469 3000100470 3000101888 3000101932 3000105387 3000106634 3000109452 3000048614 3000049263 3000049312 3000051297 3000051298 3000051299 3000053766 3000054338 3000054822 3000056937 3000059457 3000061523 3000065132 3000065723 3000066692 3000068136 3000068729 3000069123 3000070427 3000071290 3000071720 3000072523 3000074027 3000075916 3000075921 3000076853 3000079931 3000077809 3000079514 3000079515 3000080102 3000080731 3000083201 3000083202 3000085815 3000086856 3000086863 3000088104 3000088696 3000091478 3000091697 3000093943 3000097844 3000098672 3000101842 3000105735 3000108049 3000108048 3000113622 3000115918 3000049792 3000057344 3000058579 3000059459 3000064514 3000065131 3000066767 3000068137 3000073521 3000074028 3000083199 3000085816 3000089283 3000091479 3000094938 3000097938 3000100471 3000101844 3000109451 3000066138 3000069441 3000069655 3000071127 3000072522 3000073968 3000079897 3000080464 3000082658 3000083203 3000084566 3000086902 3000101585 3000101586 3000103054 3000107908 3000110206 3000056261 3000056262 3000061585 3000076852 3000082252 3000100001 3000100147 3000101521 3000094153 3000094937 3000103155 3000103917 3000105386 3000106635
- 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)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
Kit Lot Number: 3000047635 3000048712 3000048711 3000049311 3000051296 3000052326 3000053634 3000054821 3000056194 3000057204 3000058417 3000059272 3000059273 3000061448 3000062934 3000065133 3000065724 3000066487 3000068135 3000069877 3000071129 3000071890 3000073519 3000074021 3000075917 3000076955 3000079930 3000077811 3000079055 3000079517 3000080673 3000082253 3000083197 3000084068 3000084852 3000084853 3000085756 3000086925 3000088673 3000089610 3000091320 3000091698 3000093895 3000096739 3000100472 3000101934 3000105734 3000106532 3000106533 3000109449 3000113519 3000116780 3000047354 3000047707 3000048027 3000048963 3000050259 3000051645 3000051646 3000052792 3000054317 3000054873 3000056073 3000057383 3000058898 3000058899 3000059609 3000061524 3000062026 3000063084 3000064055 3000066140 3000066513 3000066514 3000068859 3000070407 3000071128 3000071415 3000073402 3000074029 3000075865 3000077274 3000080105 3000077560 3000079568 3000080106 3000080444 3000080732 3000082660 3000083200 3000084477 3000085500 3000085845 3000086491 3000089458 3000090850 3000091740 3000093114 3000094658 3000095998 3000095999 3000098650 3000100381 3000102537 3000103918 3000105531 3000106633 3000109450 3000110736 3000113520 3000115115 3000048818 3000049422 3000049791 3000051295 3000053635 3000054874 3000057267 3000058418 3000058848 3000059458 3000061477 3000062027 3000065130 3000065722 3000066766 3000068923 3000070426 3000070663 3000071289 3000072588 3000072587 3000073520 3000074020 3000075914 3000076953 3000076954 3000079932 3000077810 3000079516 3000080539 3000082534 3000083198 3000084476 3000085814 3000086855 3000088103 3000089732 3000091321 3000091322 3000093116 3000094007 3000100469 3000100470 3000101888 3000101932 3000105387 3000106634 3000109452 3000048614 3000049263 3000049312 3000051297 3000051298 3000051299 3000053766 3000054338 3000054822 3000056937 3000059457 3000061523 3000065132 3000065723 3000066692 3000068136 3000068729 3000069123 3000070427 3000071290 3000071720 3000072523 3000074027 3000075916 3000075921 3000076853 3000079931 3000077809 3000079514 3000079515 3000080102 3000080731 3000083201 3000083202 3000085815 3000086856 3000086863 3000088104 3000088696 3000091478 3000091697 3000093943 3000097844 3000098672 3000101842 3000105735 3000108049 3000108048 3000113622 3000115918 3000049792 3000057344 3000058579 3000059459 3000064514 3000065131 3000066767 3000068137 3000073521 3000074028 3000083199 3000085816 3000089283 3000091479 3000094938 3000097938 3000100471 3000101844 3000109451 3000066138 3000069441 3000069655 3000071127 3000072522 3000073968 3000079897 3000080464 3000082658 3000083203 3000084566 3000086902 3000101585 3000101586 3000103054 3000107908 3000110206 3000056261 3000056262 3000061585 3000076852 3000082252 3000100001 3000100147 3000101521 3000094153 3000094937 3000103155 3000103917 3000105386 3000106635
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2839-2020
Related Recalls
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
There is discrepant labeling on the inner and outer packaging of the device.