Z-0299-05

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

Name: Z-0299-05 Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation...
Creator: Baxter Healthcare Renal Div
Published: 2004-12-02
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2004-12-02 / 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 2004-12-02. The reason FDA records is "The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0299-05
Status: Terminated
Initiated: 2004-12-02
Posted: 2004-12-08
Terminated: 2006-07-21
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 instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 12/2/04 to all Meridian customers on the same date. The letters informed the accounts of the potential for disconnection of the power cord and teh potential for arcing, fire or electrical shock. The accounts were requested to examine their instruments to see if a new power cord clamp has been installed on the unit, using the enclosed instructions and complete the enclosed reply sheet indicating the number of units already corrected, and the number of units still requiring the power cord clamp. The accounts were requested to fax the completed reply for to Baxter at 847-270-5457.
Quantity in commerce: 3,004 units
Distribution: Nationwide and internationally to Mexico, China and Korea.
Product codes and lots: serial numbers 200101 to 202190

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)