The Recall Desk
HighFDA (Devices)·Z-1791-2021·Announced 2021-06-09

Terumo Sarns TCM II cardiac temperature controller cleaning protocol failure

The Sarns TCM II temperature control system used in cardiac surgery has been recalled due to inability to validate its cleaning protocol. Users are instructed to discontinue use and dispose of all affected devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The device is a risk-of-harm product used in critical cardiac procedures where cleaning failure could result in contamination or malfunction. However, no illnesses or injuries have been reported in the source text, and the hazard is regulatory and theoretical rather than demonstrated. This meets the High severity criterion for risk-of-harm products without reported injury.

Plain-English summary

The Sarns TCM II is a temperature-controlled water system used during cardiac surgery and extracorporeal circulation procedures (heart-lung bypass). The device supplies temperature-controlled water for blood heat exchangers, provides cooling and heating for patient blankets, supplies water for cardioplegia systems, and monitors patient and circuit temperatures.

Terumo Cardiovascular Systems Corporation issued this recall because it was unable to validate a cleaning protocol that satisfies current FDA regulatory requirements. The company determined that the best course of action is for users to discontinue use of all affected devices and dispose of them.

This recall affects 995 devices distributed domestically and internationally to 35 countries including Australia, Canada, Japan, and others. All lot numbers of the TCM II distributed from May 2, 1985 through June 10, 2015 are affected.

Healthcare facilities and clinical staff using the Sarns TCM II should discontinue use immediately and dispose of the device according to applicable medical device disposal regulations.

The recalled product

Product
The Sarns 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 extracorpor
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiac Surgery / Cardiopulmonary Bypass
Hazard
  • sterilization-failure
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lot numbers distributed from 05/02/1985 thru 06/10/2015

Distribution

Distribution scope not specified by the agency.

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