Z-1416-2018 Class II Terminated
FDA device recall Z-1416-2018 was initiated by Terumo Cardiovascular Systems Corporation on Mar 16, 2018 and is designated Class II. Reason for recall: Update to cooler-heater cleaning instructions. The recall status is terminated (terminated Jun 10, 2020). Affected quantity: 2393 this total is for all products.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Mar 16, 2018
- Termination Date
- Jun 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2393 this total is for all products
Product Description
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.
Reason for Recall
Update to cooler-heater cleaning instructions.
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.
Code Information
All Lot Codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1416-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026