3T Heater Cooler System Recalled for Incorrect Maintenance Schedule Information
LivaNova recalls 37 units of the 3T Heater Cooler System due to incorrect maintenance schedule information in the Quick Reference Guide. No injuries reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a documentation and labeling error with no reported illnesses or injuries. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (2).
Plain-English summary
LivaNova Deutschland GmbH is recalling 37 units of the 3T Heater Cooler System, model REF: 16-02-85. This medical device is distributed to healthcare facilities across the United States.
The Quick Reference Guide labeling provided with the device contains incorrect information in the maintenance schedule section. The inaccurate maintenance instructions could affect proper device maintenance and operation.
The affected systems were distributed nationwide to healthcare facilities in California, Indiana, Georgia, North Carolina, Texas, Arizona, Florida, Minnesota, New Jersey, Colorado, and South Carolina. The specific affected units are identified by a unique UDI code and corresponding serial numbers.
No illnesses or injuries have been reported in relation to this labeling discrepancy. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 3T Heater Cooler System, REF: 16-02-85
- Manufacturer
- LivaNova Deutschland GmbH
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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