Z-0758-04

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

Name: Z-0758-04 Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation...
Creator: Baxter Healthcare Renal Div
Published: 2004-03-10
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2004-03-10 / 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 2004-03-10. The reason FDA records is "Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0758-04
Status: Terminated
Initiated: 2004-03-10
Posted: 2004-07-20
Terminated: 2006-10-26
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: Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
FDA root cause: Other
Action: Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2. Baxter developed a permanent fix -- an enhanced air detector with improved sensitivity, making it capable of detecting air bubbles of a smaller size. Letters were sent to all Meridian customers on 7/11/05, informing them of the availability of the new detector and that a Baxter Field Service Engineer would contact them to schedule the upgrade.
Quantity in commerce: 2,949 units
Distribution: Nationwide, Mexico, China and Korea.
Product codes and lots: all serial numbers

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)