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
Product summary
- 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
particulate matter