Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- 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: 3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152
- 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)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Product Codes/Lot Numbers:
Kit Lot Number: 3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2831-2020
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.