FDAFDA · Food and drugs·Recall number Z-2129-2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Published August 8, 2012 · Recall initiated: April 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Nationwide distribution
- Lot
- Part Number 460730418 510(k) K052865 Lot number 2444750
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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