FDA Announces a Recall for Terumo’s Sarns TCM and TCM II Cooling and Heating Systems

  • Stockert 3T Medical Record Review & Outsourcing Services

The U.S. FDA announced a recall for Terumo’s Sarns TCM and TCM II Cooling and Heating Systems used for regulating patient body temperature during surgery. The FDA was prompted to take this decision after Terumo sent a letter to customers informing them about the new cleaning instructions after they found a potential for nontuberculous mycobacterium (NTM) to grow in the water tanks of the recalled units, which could be transferred to patients, resulting in infections and other adverse events, particularly for patients undergoing cardiovascular surgery.

The Terumo products recalled by FDA are Sarns TCM (Temperature Control and Monitor Unit) and TCM II Cooling and Heating Systems, and HX2 Temperature Management Systems. The infection is similar to the one caused by Sorin 3T Heating and Cooling System. Around 450 Sarns Devices may be affected by the recall.

Stockert 3T Heater-Cooler Systems manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), extensively used in heart surgeries across the U.S. to regulate the patient body temperature, has also been linked to NTM infections.

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