Z-0169-2007

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

Name: Z-0169-2007 Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal...
Creator: Baxter Healthcare Renal Div
Published: 2006-09-06
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2006-09-06 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A on 2006-09-06. The reason FDA records is "The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0169-2007
Status: Terminated
Initiated: 2006-09-06
Posted: 2006-11-14
Terminated: 2006-12-20
Recalling firm: Baxter Healthcare Renal Div
Product: Meridian Hemodialysis Instrument, product code 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 Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
FDA root cause: Other
Action: Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute for clinical monitoring of the patient for adverse events.' Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 2. General questions were directed to The Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 2,823 units
Distribution: Nationwide and Hong Kong, Korea and China
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)