FDAFDA · Food and drugs·Recall number Z-2837-2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Published September 2, 2020 · Recall initiated: July 27, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential Endotoxin Contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
- Lot
- Kit Lot Number: 3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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