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
Product summary
- 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
particulate matter