Gambro Renal Products, Inc. Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
Brand
Gambro Renal Products, Inc.
Lot Codes / Batch Numbers
Serial numbers: 11637 thru 12321.
Products Sold
Serial numbers: 11637 thru 12321.
Gambro Renal Products, Inc. is recalling Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco due to Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IN, NC, VA
Page updated: Jan 10, 2026