FDA-Device2016-01-13Class II

Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

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
77,136 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2016

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