Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-co...
FDA Device Recall #Z-2208-2016 — Class II — June 8, 2016
Recall Summary
| Recall Number | Z-2208-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Terumo Cardiovascular Systems Corporation |
| Location | Ann Arbor, MI |
| Product Type | Devices |
| Quantity | 6412 units |
Product Description
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 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.
Distribution Pattern
Domestic: 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 Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Germany Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates , Uruguay , Venezuela, Vietnam
Lot / Code Information
The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747
Other Recalls from Terumo Cardiovascular Systems Corpora...
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|---|---|---|---|
| Z-2018-2025 | Class II | CDI OneView System BPM Probe: Cat. No. CDI75... | May 28, 2025 |
| Z-1492-2025 | Class II | Terumo CDI OneView Monitoring System Hematocrit... | Mar 3, 2025 |
| Z-1401-2024 | Class II | Cardiovascular Procedure Kits that include High... | Feb 20, 2024 |
| Z-1346-2023 | Class II | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Nu... | Mar 1, 2023 |
| Z-1347-2023 | Class II | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Nu... | Mar 1, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.