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Terminated

Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

FDA Recall Z-0947-05 · Posted 2005-06-30

Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKDI
Date Initiated2003-10-03
Date Terminated2005-07-01
Product Quantity2986 units

Reason for Recall

The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide, Korea, Mexico, Guatemala, China and Hong Kong

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992894MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576Baxter Healthcare Corp · 1999-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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