Terumo recalls Sarns Temperature Control and Monitor units (TCM) due to unvalidated cleaning protocol. Affected units from 1985-2015 may cause infection if not cleaned properly. Discontinue use and dispose of affected models.
Terumo CVS 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.
Terumo is recalling Sarns Temperature Control and Monitor units (TCM) because they cannot be cleaned safely. These devices are used for blood temperature control in medical procedures. If you have the recalled units, stop using them immediately to avoid infection risks.
The devices cannot be cleaned safely due to unvalidated protocols. This means improper cleaning could lead to infections in patients or medical staff using the units for blood temperature control during procedures.
Medical professionals using the TCM units for blood temperature control in extracorporeal circuits are most at risk. Patients receiving these devices for temperature management could be affected if the units are not properly cleaned.
Check for TCM II TUV models with 115V (P/N 4415) or 220V (P/N 4416) from 1985 to 2015. The catalog numbers 4416 and 164940 are also associated with these units.
Discontinue use and dispose of all affected TCM units immediately to prevent infection risks.
Terumo cannot validate a cleaning protocol for these units, so they must be discontinued to prevent infection risks.
TCM II TUV models with 115V (P/N 4415) or 220V (P/N 4416) from 1985 to 2015, and catalog numbers 4416 and 164940.
Yes, you must dispose of the units immediately as they cannot be cleaned safely.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1790-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1790-2021 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
