Device product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Z-2128-2012
Product summary
- Event
- Event 62538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4625
- Official record key
device-enforcement:Z-2128-2012
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 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
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.