Gambro Renal Products, Inc. Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Brand
Gambro Renal Products, Inc.
Lot Codes / Batch Numbers
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
Products Sold
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
Gambro Renal Products, Inc. is recalling Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, S due to Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
Recommended Action
Per FDA guidance
Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
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