Reported Oct 18, 2023 · Ongoing
3T Heater Cooler System, REF: 16-02-85
LivaNova Deutschland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova Deutschland GmbH · Lindberghstr. 25 · Munich, N/A · N/A
Is this the product you have?
- 3T Heater Cooler System
- REF16-02-85
- Lot codes and dates
- UDI(01)04033817900528/
- Serial Numbers
20T3133420T3133620T3136620T3139120T3137520T3132220T3134820T3134520T3136220T3136320T3136420T3140720T3153120T3153220T3153420T3136720T3136820T3136920T3137020T3137120T3137220T3137320T3138620T3138720T3138820T3138920T3139020T3155020T3155120T3155220T3155320T3154320T3154420T3153620T3134620T3134720T3136120T31365
- Amount recalled
- 37 systems
Where it was sold
Why it was recalled
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
This product could cause temporary or reversible health problems — stop using it.
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