High Pressure Stopcock — Class II medical device recall Z-2128-2012
Terminated recall by ICU Medical, Inc., reported 2012-08-08, distributed nationwide. The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of
| Recall number | Z-2128-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2012-04-17 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2012-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 4,625 |
| Lot numbers | 2432974, 2441508, 2448504, 2455568 |
| Model numbers | 423530401, 510 |
Product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2128-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.