The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Terumo Sarns™ TCM II Cooling and Heating Systems manufactured by Terumo Cardiovascular Systems Corporation, imported and distributed by Terumo Marketing Philippines, Inc.:
|Item Code||Description||Affected Lot Numbers|
|164925||TCM II, with Cardioplegia, 110V/60Hz||
All lot numbers distributed from 05/02/1985 to 06/10/2015
|164930||TCM II, without Cardioplegia, 110V/60Hz|
|164935||TCM II, with Cardioplegia, 220V/50Hz|
|164940||TCM II, without Cardioplegia, 220V/50Hz|
Terumo Marketing Philippines, Inc. initiated the voluntary recall of the above-mentioned lots/batches of Terumo Sarns™ TCM II Cooling and Heating Systems in the Philippines due to the medical device recall done by the US FDA (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=187216). Based on the medical device recall done by the US FDA, the Terumo Cardiovascular Systems Corporation initiated the removal of all lot numbers distributed from 05/02/1985 to 06/10/2015 of Terumo Sarns™ TCM II Cooling and Heating Systems after the manufacturer has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations.
As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
In light of the foregoing, all concerned healthcare professional, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Terumo Sarns™ TCM II Cooling and Heating Systems.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.