Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
FDA Recall Z-0605-03 · Posted 2003-03-05
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDI
Date Initiated2002-11-15
Date Terminated2003-09-19
Product Quantity2864 units
Reason for Recall
Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
Firm Action
Baxter issued a Safety Alert letter dated 11/15/02 to the direct accounts informing them of the potential for incomplete disinfection of the Meridian instrument during the Renalin/Formalin disinfection cycle due to electomagnetic interference (EMI). The accounts were informed that they will be receiving a radio frequency interference (RFI) filter kit and installation instructions to eliminate EMI by 2/28/03. The accounts were given instructions to follow to ensure that the Renalin/Formalin disinfection cycle has been completed prior to use of the machine.
Root Cause
Other
Distribution Pattern
Nationwide, Mexico, China, South Korea, Hong Kong
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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