Reported Aug 8, 2012 · Terminated
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- High Pressure Stopcock (3-Way, Luer Lock, Off)
- Product UsageFor IV
- Lot codes and dates
- Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
- Amount recalled
- 4625
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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