Device product
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
Z-0606-2016
Product summary
- Event
- Event 72787
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9600 units
- Official record key
device-enforcement:Z-0606-2016
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: GR324012, GR325322, GR326769, and GF328518
Distribution pattern: US Nationwide Distribution and the country of Canada
Derived failure modes
-
Foreign material or chemical contamination
particulate matter