FDA-Device2016-01-13Class II

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.

Baxter Healthcare Corp.
Hazard

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

Sold states
US Nationwide Distribution and the country of Canada
Affected count
9264 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0605-2016

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