FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: 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.
- Recall number
- Z-1056-2017
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Status
- Terminated
- Initiated
- 2016-12-16
- Posted
- 2017-01-19
- Terminated
- 2017-08-24
- Reason
- Customer complaints received for the presence of leaks
- Root cause
- Device Design
- Action
- An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
- Quantity
- 8640 eaches
- Distribution
- US only
- Lot, serial or model codes
- H16F16088
- 510(k) numbers
- ["K102936"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28