Gambro Renal Products, Inc. Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Brand
Gambro Renal Products, Inc.
Lot Codes / Batch Numbers
Serial numbers: PA0101 to PA0681.
Products Sold
Serial numbers: PA0101 to PA0681.
Gambro Renal Products, Inc. is recalling Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy. due to A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 05/16/2006.
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 noticePage updated: Jan 10, 2026