FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- Recall number
- Z-1316-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- Status
- Open, Classified
- Initiated
- 2023-02-22
- Posted
- 2023-04-01
- Terminated
- not on file
- Reason
- The electrical safety testing was not properly performed on the impacted devices and additional testing is required
- Root cause
- Process design
- Action
- Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.
- Quantity
- 16 units
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Lot, serial or model codes
- Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
- 510(k) numbers
- ["K201867"]
- 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