Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
all serial numbers with software version 4.0 or below
Products Sold
all serial numbers with software version 4.0 or below
Baxter Healthcare Renal Div is recalling Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corpora due to The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026