Recall Z-1416-2018
Terumo Cardiovascular Systems Corporation · initiated March 16, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Codes / lots: All Lot Codes
Reason for recall
Update to cooler-heater cleaning instructions.
FDA-determined cause: Labeling design
Action taken
The firm,Terumo Cardiovascular Systems Corporation, mailed customers an "Urgent Medical Device Correction" letter dated 2/16/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) discard the current Sarns TCM, TCM II Cooling and Heating, or tHX2 Temperature Management Systems cleaning guides; 2) Review the notice and updated cleaning guides, and ensure all users receive notice of the updated cleaning guides and; 3) Return the Customer Response Form acknowledging receipt of the notice via Terumo Recall Email: tcvs.recall@terumomedical.com or Terumo Recall Fax: 734-741-6149. The letter also includes a list of the updates to the cleaning guides. Customers with questions may contact Terumo CVS Customer Service (800) 521-2818, Monday-Friday, 8am-6pm ET or Fax (734)741-6149.
Details
- Recall number
- Z-1416-2018
- Initiated
- March 16, 2018
- Posted by FDA
- April 18, 2018
- Terminated
- June 10, 2020
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 2393 this total is for all products
- Distribution
- Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and…
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1417-2018 Class II | Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring…Update to cooler-heater cleaning instructions. | 03/16/2018Terminated |
| Z-1418-2018 Class II | Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI…Update to cooler-heater cleaning instructions. | 03/16/2018Terminated |