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[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

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductBaxter 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 / manufacturerBaxter Healthcare Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0606-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date30 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 →

Related recalls from Baxter Healthcare Corp.

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.

Shop Recalled Baxter INTERLINK System
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