Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
FDA Recall Z-0695-2007 · Posted 2007-03-31
Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2007-01-04
Date Terminated2012-01-03
Product Quantity153 units (Domestic)
Reason for Recall
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)
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.