Recalls / —
—#162905
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.
- FDA product code
- DWC — Controller, Temperature, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K071521
- Affected lot / code info
- All Lot Codes
Why it was recalled
Update to cooler-heater cleaning instructions.
Root cause (FDA determination)
Labeling design
Action the firm took
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.
Recalling firm
- Firm
- Terumo Cardiovascular Systems Corporation
- Address
- 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586
Distribution
- Distribution pattern
- 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 Vietnam.
Timeline
- Recall initiated
- 2018-03-16
- Posted by FDA
- 2018-04-18
- Terminated
- 2020-06-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162905. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.