FDA Device

Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.

Hazard

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)

What You Should Do

Remedy

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.

Products

Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Brand
Gambro Renal Products, Inc.
UPC
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.

Units Affected

153 units (Domestic)