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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-0299-05 · Posted 2004-12-08

Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKDI
Date Initiated2004-12-02
Date Terminated2006-07-21
Product Quantity3,004 units

Reason for Recall

The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.

Firm Action

Baxter sent Urgent Device Correction letters dated 12/2/04 to all Meridian customers on the same date. The letters informed the accounts of the potential for disconnection of the power cord and teh potential for arcing, fire or electrical shock. The accounts were requested to examine their instruments to see if a new power cord clamp has been installed on the unit, using the enclosed instructions and complete the enclosed reply sheet indicating the number of units already corrected, and the number of units still requiring the power cord clamp. The accounts were requested to fax the completed reply for to Baxter at 847-270-5457.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Mexico, China and Korea.

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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