3T Heater Cooler System recall: Labeling Error
3T Heater Cooler System, REF: 16-02-85
Why was 3T Heater Cooler System recalled?
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 3T Heater Cooler System, REF: 16-02-85
- Recalling firm
- LivaNova Deutschland GmbH
- Quantity
- 37 systems
- Distribution
- US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)