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Warmer, Irrigation Solution

FDA product code LHC · Class 1 · Physical Medicine

783
Registered devices
211
Adverse events
10
Recalls
24
510(k) clearances

Devices with this code

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 36”T — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC.COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x24.5”T — FUTURE HEALTH CONCEPTS, INC.Counter Top Blanket/Fluid Warming Cabinet Overall size 30”W x 26.5”D x24.5”T — M.A.C. MEDICAL INC.TRIPLE CHAMBER WARMING CABINET — FUTURE HEALTH CONCEPTS, INC.SINGLE CHAMBER WARMING CABINET — M.A.C. MEDICAL INC.SINGLE CHAMBER WARMING CABINET GLASS DOOR — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC.DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T — M.A.C. MEDICAL INC.SINGLE CHAMBER WARMING CABINET GLASS DOOR — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 24"W x 20.5"D x 64 — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET/FLUID WARMER, GLASS DOOR — FUTURE HEALTH CONCEPTS, INC.COUNTER TOP BLANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 24"W x 20.5"D x 24. — M.A.C. MEDICAL INC.SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 36”T — FUTURE HEALTH CONCEPTS, INC.SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size Freestanding 24”W x 20.5”D x — FUTURE HEALTH CONCEPTS, INC.SINGLE CHAMBER BLANKET/FLUID WARMER — M.A.C. MEDICAL INC.SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 36”T — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC.SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 20.5”D x 36”T — M.A.C. MEDICAL INC.DUAL CHAMBER BLANKET/FLUID WARMER — M.A.C. MEDICAL INC.DUAL BLANKET / FLUID WARMING CABINET — FUTURE HEALTH CONCEPTS, INC.DUAL CHAMBER WARMING CABINET — M.A.C. MEDICAL INC.TRIPLE CHAMBER WARMING CABINET, GLASS DOORS — M.A.C. MEDICAL INC.SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC.

Recent recalls

DateFirmReason
2016-10-25Smiths Medical ASD, Inc.Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-25Resource Optimization & Innovation LlcCustom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting steri
2015-08-18Ecolab IncThe sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compro

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.