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°M Warmer System - Starter Kit+

Mequ A/S · Model MWS006 · UDI-DI 05745000140022

BSB LGZ Prescription

510(k) clearances

2,225

Adverse events (23 deaths)

Recalls

Facilities

Description

The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).

Recalls

Date	Firm	Reason
2025-04-10	3M Company	Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
2014-07-25	Estill Medical Technologies, Inc	Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Ba

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.