FDA Device recall Z-2208-2016
Sarns TCM
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of Sarns TCM by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2208-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-08 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) 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 The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicated for controlling and monitoring patient temperature.
Reason
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Identifiers
| code_info | The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2208-2016%22
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