APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure
FDA device recall Z-1056-2017 · posted 2017-01-19 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Customer complaints received for the presence of leaks
- Action taken
- An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 8640 eaches
- Distribution
- US only
- Date initiated
- 2016-12-16
- Date posted
- 2017-01-19
- Date terminated
- 2017-08-24
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936) | Baxter Healthcare Corp | 2011-03-30 |