[Recalled] Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit — The firm initiated the recall due to a molding defect in a high pressure stopco… | FDA 2012-04-17
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit |
|---|---|
| Brand / manufacturer | ICU Medical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2131-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 April 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from ICU Medical, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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