Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a containe…

Recall date
November 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0605-2016
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
US Nationwide Distribution and the country of Canada

Why it was recalled

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.

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