Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
Hazard
Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
What You Should Do
Remedy
Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers.
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Products
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
- Brand
- Gambro Renal Products, Inc.
- UPC
- Serial numbers: 11637 thru 12321.
Units Affected
613 machines (US), 170 machines (foreign)