Skip to main content

Sarns TCM and TCM II Cooling & Heating Systems Recalled

Sarns TCM and TCM II Cooling & Heating Systems Recalled

Sarns TCM and TCM II Cooling & Heating Systems Recalled

Introduction

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.

Comments

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.

Latest News

NC to Get $150M to Boost Opioid Treatment, Recovery

Categories: Opioids

North Carolina will receive an additional $150 million from Purdue Pharma and the Sackler family as part of a national $7.4 billion settlement related to the opioid

SRI Gets FDA OK for High-Dose Naloxone Trial

Categories: Opioids

SRI has received authorization from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials of a new, high-dose injectable naloxone formulation.

The approval was granted under an Investigational New Drug (IND)…

Spokane County to Get $5M in New Opioid Settlement

Categories: Opioids

Jurisdictions within Spokane County are set to receive nearly $4.7 million as part of a sweeping $7.4 billion nationwide settlement with Purdue Pharma and its owners, the Sackler family.

The agreement addresses the company’s role in fueling…

✍️ FREE—3000 Pages Medical Record Review Trial!                
No Contract. No Risk—Fully Customized, Free!

Only 10 Firms Accepted—Offer Ends June 30!