Recall archive / FDA device enforcement
3T Heater Cooler System, REF: 16-02-85 — FDA record Z-0073-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 3T Heater Cooler System, REF: 16-02-85
- Reason
- The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
- Classification
- Class II
- Recalling firm
- LivaNova Deutschland GmbH
- Quantity
- 37 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0073-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 18, 2023
- Recall initiation date
- Aug 3, 2023
- Center classification date
- Oct 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.