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Moist Hot-Pack Unit
KARIS Co.,Ltd · Model KRS-12P-A1D32 · UDI-DI 08809520550451
7
510(k) clearances
38
Adverse events
1
Recalls
48
Facilities
Description
It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-11-15 | Biomet Microfixation, LLC | On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled |
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