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Recall Observatory FDA recall evidence

Device product

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.

Z-0607-2016

November 30, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 72787
Status
Terminated
Classification
Class II
Quantity
77,136 units
Official record key
device-enforcement:Z-0607-2016

Official wording

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

Code information: Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534

Distribution pattern: US Nationwide Distribution and the country of Canada

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter