FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp: Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Recall number
- Z-3133-2017
- Recalling firm
- Baxter Healthcare Corp
- Product
- Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Status
- Terminated
- Initiated
- 2017-09-01
- Posted
- not on file
- Terminated
- 2019-08-27
- Reason
- The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
- Root cause
- Equipment maintenance
- Action
- The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
- Quantity
- 164,700 units
- Distribution
- nationwide, Canada
- Lot, serial or model codes
- Lot numbers: H16G28107, H16H01086, H16H04114, H16H09063, H16H13032, H16H19112, H16H26034, H16H30010, H16I02017, H16I06018, H16I08071, H16I12016, H16I14103, H16I16066, H16I19060, H16I21058, H16I23047, H16I26065, H16I30091, H16J03014, H16J05035, H16J07015, H16J09078, H16J11132, H16J14011, H16J16057, H16J18046, H16J20109, H16J22063, H16J24127, H16J26072, H16J28128, H16J30058, H16K01057, H16K03079, H16K05041, H16K07054, H16K08086, H16K10090, H16K28027, H16K30015, H16L04034, H16L11039, H16L15105
- 510(k) numbers
- ["K151525"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 2314912
- Firm city
- Mountain Home
- Firm state
- AR
- 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