Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0605-2016

November 30, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 72787
Status
Terminated
Classification
Class II
Quantity
9264 units
Official record key
device-enforcement:Z-0605-2016

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: GR323998, GR325035, GR326082, and GR327965

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