Recall Z-2218-2012— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2218-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-20

Class III · Terminated

Class III FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-06-20, terminated 2012-11-07. It names one FDA 510(k) clearance: K915183. Product: System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.. Reason: During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc.

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class III
Status: Terminated
Initiated: 2012-06-20
Terminated: 2012-11-07
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K915183 — SARNS 8000 MODULAR PERFUSION SYSTEM3M Health Care, Sarns·cleared 1992-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Reason for recall

During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc

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