Device product
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Z-2129-2012
Product summary
- Event
- Event 62538
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2129-2012
Official wording
Reason: 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.
Code information: Part Number 460730418 510(k) K052865 Lot number 2444750
Distribution pattern: Nationwide distribution
Derived failure modes
-
Unknown
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.