Z-0947-05

Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation...

Name: Z-0947-05 Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation...
Creator: Baxter Healthcare Renal Div
Published: 2003-10-03
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2003-10-03 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A on 2003-10-03. The reason FDA records is "The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0947-05
Status: Terminated
Initiated: 2003-10-03
Posted: 2005-06-30
Terminated: 2005-07-01
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
FDA 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 in commerce: 2986 units
Distribution: Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
Product codes and lots: all serial numbers with software version 4.0 or below

Product code KDI

K992894Class IIMeridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp / cleared 1999-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)