Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
FDA device recall Z-1417-2018 · posted 2018-04-18 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Update to cooler-heater cleaning instructions.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- DWC
- Quantity affected
- 2393- total 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, J
- Date initiated
- 2018-03-16
- Date posted
- 2018-04-18
- Date terminated
- 2020-06-10
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEMPERATURE CONTROL & MONITOR (K841402) | Sams, Inc. | 1984-06-11 |