Recall Z-2209-2016— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2209-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-08

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2016-06-08, terminated 2017-08-04. It names one FDA 510(k) clearance: K883603. Product: Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitoring patient temperature.. Reason: Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Terminated: 2017-08-04
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K883603 — SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)3M Health Care, Sarns·cleared 1988-11-03

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

Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitoring patient temperature.

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

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