Terumo recalls Sarns TCM II blood heat exchangers due to inability to validate cleaning protocols. Affected units must be discontinued and disposed of to prevent potential safety risks.
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 TCM II blood heat exchangers because they cannot validate a cleaning protocol that meets regulatory standards. Users must stop using and dispose of these devices to avoid potential safety risks.
The devices cannot be cleaned according to regulatory standards, which could lead to unsafe conditions. This failure means the equipment might not function properly during medical procedures, potentially causing harm to patients.
Medical professionals using the Sarns TCM II blood heat exchangers for extracorporeal circuits or patient warming are affected. Patients receiving this equipment are at risk if the device is not properly maintained.
Check for the model numbers TCM II with or without Cardioplegia, 110V/60Hz or 220V/50Hz, and catalog numbers 4415, 164925, 164930, 164935, or 15747. Units distributed from May 2, 1985, through June 10, 2015, are affected.
Immediately discontinue use and dispose of all affected Sarns TCM II blood heat exchangers.
Terumo cannot validate a cleaning protocol that meets regulatory standards, so they recommend discontinuing use and disposal of the devices.
TCM II with Cardioplegia (110V/60Hz and 220V/50Hz), TCM II without Cardioplegia (110V/60Hz and 220V/50Hz), and TCM (P/N 15747).
Units distributed from May 2, 1985, through June 10, 2015.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1791-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1791-2021 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.
