Sarns TCM II — Class II medical device recall Z-2209-2016
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2016-07-27, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due t
| Recall number | Z-2209-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2016-06-08 |
| Classified | 2016-07-18 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-08-04 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DO, EC, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IR, IT, JM, JO, JP, KR, LB, MT, MX, MY, NL, NO, NZ, PH, PT, RU, SA, SE, SG, SV, TH, TR, TW, UY, VE, VN |
| Quantity | 6,412 units |
Product
Sarns TCM II; The Sarns Temperature Control and Monitor unit (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 extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitoring patient temperature.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2209-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.