Recall Z-2261-2013— Terumo Cardiovascular Systems Corporation

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2013-07-26, terminated 2015-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.. Reason: Medical device used in cardiovascular procedures is defective..

Recalling firm

Terumo Cardiovascular Systems Corporation

Classification

Class II

Status

Terminated

Initiated

2013-07-26

Terminated

2015-07-28

Firm location

Elkton, MD, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.