[Recalled] Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. . |
|---|---|
| Brand / manufacturer | Baxter Healthcare Corp. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0606-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 30 November 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
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 →
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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.