Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL

FDA device recall Z-0605-03 · posted 2003-03-05 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.

Action taken

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

Status

Terminated

Product code

KDI

Quantity affected

2864 units

Distribution

Nationwide, Mexico, China, South Korea, Hong Kong

Date initiated

2002-11-15

Date posted

2003-03-05

Date terminated

2003-09-19

Location

Round Lake, IL