FDA Device recall Z-2210-2016
Preamendments device-Sarns Dual Cooler-Heater
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of Preamendments device-Sarns Dual Cooler-Heater 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 Inter chlor sanitizer (Produc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2210-2016 |
| 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
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.
Reason
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Identifiers
| code_info | The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160); Dual Cooler Heater 220V/50Hz (P/N 4332); Dua…The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160); Dual Cooler Heater 220V/50Hz (P/N 4332); Dual Cooler Heater 1 OOV/60Hz (P/N 14114); Dual Cooler Heater 1 OOV/50Hz (PIN 13460) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2210-2016%22
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