Device product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Z-1653-2022
Product summary
- Event
- Event 90730
- Status
- Terminated
- Classification
- Class I
- Quantity
- 511,728 units
- Official record key
device-enforcement:Z-1653-2022
Official wording
Reason: Firm noted an increase in customer reports of leaks.
Code information: UDI/DI 00085412656649, All lots within expiry
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Firm noted an increase in customer reports of leaks.