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.
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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)