Recalls / —
—#151903
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.
- FDA product code
- FKX — System, Peritoneal, Automatic Delivery
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K102936
- Affected lot / code info
- H16F16088
Why it was recalled
Customer complaints received for the presence of leaks
Root cause (FDA determination)
Device Design
Action the firm took
An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- US only
Timeline
- Recall initiated
- 2016-12-16
- Posted by FDA
- 2017-01-19
- Terminated
- 2017-08-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.