Device product
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
Z-1056-2017
Product summary
- Event
- Event 75998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8640 eaches
- Official record key
device-enforcement:Z-1056-2017
Official wording
Reason: Customer complaints received for the presence of leaks
Code information: H16F16088
Distribution pattern: US only
Derived failure modes
-
Unknown
Customer complaints received for the presence of leaks