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"DUAL CHAMBER BLANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 24""W x 20.5""D x 64"
Model FHCDWC2460-TL-G-LH-220 · M.A.C. MEDICAL INC. · DI B286FHCDWC2460TLGLH2201
LHC — Warmer, Irrigation Solution · Class I · 21 CFR 890.5950
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-09 | 0 | 3 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — M.A.C. MEDICAL INC.
Nothing in the loaded window.