Z-0605-03

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

Name: Z-0605-03 Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation...
Creator: Baxter Healthcare Corp.
Published: 2002-11-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2002-11-15 / Terminated / root cause: sterility

FDA source

Baxter Healthcare Corp. began a recall of Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high... on 2002-11-15. The reason FDA records is "Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0605-03
Status: Terminated
Initiated: 2002-11-15
Posted: 2003-03-05
Terminated: 2003-09-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
Root cause tag: sterility
FDA root cause: Other
Action: Baxter issued a Safety Alert letter dated 11/15/02 to the direct accounts informing them of the potential for incomplete disinfection of the Meridian instrument during the Renalin/Formalin disinfection cycle due to electomagnetic interference (EMI). The accounts were informed that they will be receiving a radio frequency interference (RFI) filter kit and installation instructions to eliminate EMI by 2/28/03. The accounts were given instructions to follow to ensure that the Renalin/Formalin disinfection cycle has been completed prior to use of the machine.
Quantity in commerce: 2864 units
Distribution: Nationwide, Mexico, China, South Korea, Hong Kong
Product codes and lots: product codes 5M5576, 5M5576R, serial numbers 200000 through 202864

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)