FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
- Recall number
- Z-0947-05
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
- Status
- Terminated
- Initiated
- 2003-10-03
- Posted
- 2005-06-30
- Terminated
- 2005-07-01
- Reason
- The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
- Root cause
- Other
- Action
- No official recall notificaiton was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.
- Quantity
- 2986 units
- Distribution
- Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
- Lot, serial or model codes
- all serial numbers with software version 4.0 or below
- 510(k) numbers
- K992894
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3000210122
- Firm city
- Park
- 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